BETA

Activities of Holger KRAHMER related to 2012/0266(COD)

Plenary speeches (1)

2016/11/22
Dossiers: 2012/0266(COD)

Shadow reports (1)

2016/11/22
Committee: ENVI
Dossiers: 2012/0266(COD)
Documents: PDF(1 MB) DOC(1 MB)

Amendments (94)

Proposal for a regulation
Recital 64

(64) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certificates issued by notified bodies, of the ~~minimum~~ requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system; the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 2 – point f

(f) products that contain or consist of biological substances or organisms other than those referred to in points (c) and (e) that are viable~~, including living micro- organisms, bacteria, fungi or viru~~ and that achieve their intended purpose by pharmacological, immunological or metabolic means;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 3 – introductory part

(3) ‘custom-made device’ means any device specifically made ~~in accordance with~~by an appropriately qualified person exclusively to meet a specific patient’s individual requirements and needs. In particular a ‘custom-made device’ may be produced on the basis of a written prescription of a doctor of medicine, of a dental practitioner or of any other person authorised by national law by virtue of this person'’s professional qualifications which gives, under his responsibility, specific design characteristics~~, and is intended for the sole use of a particular patient.~~. However, mass-produced devices which need to be adapted to meet the specific requirements of a doctor of medicine, a dental practitioner or any other professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of doctors of medicine, dental practitioners or any other authorised person shall not be considered to be custom-made devices;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 19 – introductory part

(19) ‘manufacturer’ means the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name ~~or trademark~~.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1

1. The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of 'medical device' or 'accessory to a medical device'. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c

(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article ~~24 and Article~~ 11(3) respectively.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 4

4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – title

Person responsible for ~~regulatory~~ compliance

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – introductory part

Manufacturers shall have available within their organisation at least one ~~qualified person~~person responsible for compliance who possesses expert ~~knowledg~~ise in the field of medical devices. The expert ~~knowledg~~ise shall be demonstrated by ~~either of the following qualifications:~~a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline necessary to fulfil the tasks laid down in paragraph 2 points (a) and (b) of this article.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point a

(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices;deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point b

~~(b) five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.~~deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 2

Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate their expert knowledge referred to in the first subparagraph by at least two years of professional experience within the relevant field of manufacture. Gaining a qualification to run a business and to train apprentices shall, in particular, be deemed to constitute proof of professional experience.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 3

This paragraph shall not apply to manufacturers of custom-made devices who are registered pharmacies, or micro- enterprises as defined by Commission Recommendation 2003/361/EC.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 2 – introductory part

2. The ~~qualified person~~person responsible for compliance shall at least be responsible for ensuring the following matters:

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 2 – point b

~~(b) that the technical documentation and the declaration of conformity are drawn up and kept up-to-date;~~deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 2 – point d

(d) ~~in the case of investigational devices, that the statement referred to in~~Where more than one person responsible for compliance is responsible for ensuring the matters pursuant to point ~~4.1~~(a) of ~~Chapter II of Annex XIV is issued~~this paragraph, the corresponding duties shall be recorded in a written form.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 3

3. The ~~qualified person~~person responsible for compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his duties.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 4 – introductory part

4. Authorised representatives shall have available within their organisation at least one ~~qualified person~~person responsible for compliance who possesses expert ~~knowledg~~ise regarding the ~~regulatory~~ requirements for medical devices in the Union. The expert ~~knowledg~~ise shall be demonstrated by ~~either of the following qualifications:~~a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline necessary to fulfil the tasks laid down in paragraph 2 points (a) and (b) of this article.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 4 – point a

(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices;deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 4 – point b

~~(b) five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.~~deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 2

A distributor, importer or other natural or legal person shall assume the obligations incumbent on the manufacturer under paragraph 1(a) only if the device in question was manufactured outside the European Union. In the case of devices manufactured within the EU, the manufacturer’s proof of compliance with the provisions of this Regulation shall suffice. The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in number (19) of Article 2(1), assembles or adapts a device already on the market to its intended purpose for an individual patient.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)

(ea) compatibility with other traceability systems used by the stakeholders involved with medical devices

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 29 – paragraph 1

1. Notified bodies shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this Regulation. ~~Minimum r~~Requirements to be met by notified bodies are set out in Annex VI.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 29 – paragraph 2

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 ~~amending or~~ supplementing the ~~minimum~~ requirements in Annex VI, in the light of technical progress and considering the ~~minimum~~ requirements needed for the assessment of specific devices, or categories or groups of devices.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 33 – paragraph 2

2. Member States ~~may~~shall notify only conformity assessment bodies which satisfy the requirements set out in Annex VI.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 33 – paragraph 4 – subparagraph 1

The notification shall clearly specify the scope of the designation indicating the conformity assessment activities, the conformity assessment procedures, the risk class and the type of devices which the notified body is authorised to assess.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 34 – paragraph 1

1. The Commission shall assign an identification number to each notified body for which the notification is accepted in accordance with Article 33. It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully renotified, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 36 – paragraph 5 – subparagraph 1 – point a

(a) in the case of suspension of a notification: on condition that, within three months of the suspension~~, either the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate is established, or~~ another notified body confirm in writing that it is assuming the functions of the notified body during the period of suspension;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 42 – paragraph 2 – subparagraph 1

Manufacturers of devices classified as class III, other than custom-made or investigational devices, shall be subject to a conformity assessment based on ~~full quality assurance and design dossier examination as specified in Annex VIII. Alternatively, the manufacturer may choose to apply a conformity assessment based on~~ type examination as specified in Annex IX coupled with a conformity assessment based on product conformity verification as specified in Annex X. .

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 42 – paragraph 10 – subparagraph 1 – indent 2

the minimum frequency of unannounced factory inspections and sample checks to be conducted by notified bodies in accordance with Section 4.4 of Annex VIII, taking into account the risk-class and the type of device;deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 44

~~[...]~~deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 44 a (new)

Article 44 a Scrutiny of Notified Bodies and of the peer review of national competent authorities responsible for Notified Bodies 1. The MDCG shall ensure: a) alignment of the initial assessment, qualification, notification and surveillance of Notified Bodies; b) monitoring of the on-going quality and competence of class III notified bodies and their assessments, and c) the notification and surveillance activities of national competent authorities responsible for Notified Bodies via the peer review referred to in Article 28 paragraph 8. 2. In order to achieve the goal in paragraph 1(a) the MDCG shall: a) have a sufficient number of competent personnel at its disposal who are qualified in the assessment of conformity assessment bodies and Notified Bodies. At least two such experts and a representative of the Commission shall participate in the joint assessment teams for the assessment of conformity assessment bodies according to paragraph 3 of Art. 32 and of Notified Bodies according to paragraph 4 of Art. 35. b) review the opinion provided by the joint assessment team regarding the assessment report and the draft notification according to paragraph 6 of Art. 32, and decide on a positive or negative recommendation. This recommendation shall be submitted to the Commission and the national authority responsible for the Notified Body. c) establish detailed qualification requirements on its experts for the assessment of conformity assessment bodies and of Notified Bodies. d) establish detailed harmonized rules for Notified Bodies and the assessments and tasks carried out by notified bodies which shall mandatorily be applied and monitored as part of the initial assessment conformity assessment bodies and monitoring of their notifications as Notified Bodies. These rules shall comprise: i. Prerequisites for assessment and notification as a Notified Body including requirements on its organisation, quality management system and processes; ii. requirements on necessary resources, including qualification and training; iii. specific requirements on auditors and technical assessors of class III Notified Bodies; iv. specific requirements on test laboratories including subcontractors; v. particular competency requirements in the areas of sterilisation processes; biocompatibility; devices containing medicinal substances, tissues and cells of human and animal origin; and clinical evaluation; vi. requirements on independency, impartiality and confidentiality; vii. detailed rules for initial assessments and surveillance assessments of manufacturers and other economic operators by notified bodies, with specific and appropriate provisions for assessment of class III and novel devices; viii. frequency of notified body surveillance assessments of manufacturers which shall be performed on a regular basis, and at least annually for class III medical device manufacturers; ix. the scope of surveillance assessments including requirement to carry out on-site assessments covering the assessment of quality management systems including vigilance, verification of validity of type examinations and design dossier examination certificates, clinical evaluations and post market surveillance plans; x. rules and criteria for surveillance assessments; due to reasonable suspicion, such assessments shall be performed primarily unannounced; xi. rules for the restriction or withdrawal of notifications; xii. rules for an arbitration procedure in the event of disagreement over a negative recommendation of an initial assessment or the restriction or withdrawal of a notification. 3. In order to achieve the goal in paragraph 1(b), three years after notification of a notified body, and again every third year thereafter, the assessment to determine whether the notified body still satisfies the requirements set out in Annex VI shall be conducted by the MDCG and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the on-going compliance of a notified body with the requirements set out in Annex VI. For notified bodies which are notified for Class III devices, this assessment shall be performed every year and inter alia include a review of samples of design dossier examinations carried out by the notified body to verify the continued quality and competence in assessing class III medical devices. 4. In order to achieve the goal in paragraph 1(c) the MDCG shall establish detailed rules for peer-reviews of national authorities responsible for Notified Bodies as defined in Article 28 paragraph 8. These rules shall be mandatorily applied to all peer-reviews which shall be performed every two years with national competent authorities responsible for Notified Bodies according to the annual plan for peer-reviews as required by Article 28 paragraph 8. 5. Members of the MDCG including at least one representative of the Commission shall participate in the peer- reviews of the national competent authorities responsible for Notified Bodies as defined in Article 28 paragraph 8. 6. The MDCG shall establish detailed requirements on the qualification of its audit experts for participation in peer- reviews as defined in Article 28 paragraph 8.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 62 – paragraph 5 a (new)

5 a. The reports and information referred to in Article 62(5), shall also be automatically transmitted for the device in question via the electronic system to the notified body that issued the certificate in accordance with Article 45.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 68 – paragraph 2

2. The information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the Member States ~~and~~, to the Commission and to the notified bodies.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point b

(b) to ~~contribute~~ regularly monitor t~~he scrutiny of certain conformity assessments pursuant to Article 44~~echnical progress, in particular for class III implantable medical devices;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point c

(c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requiremassess whether the basic requirements to the safety and performance of medical devices intended by this regulation are sufficients and ~~conduct of the clinical evaluation by manufacturers and the assessment by notified bodies;~~to identify necessary amendments to Annex I.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point d

(d) to ~~assist the competent authorities of the Member States in their coordination activit~~develop guidelines for clinical studies ion ~~the fields of clinical investigations, vigilance and market surveillance;~~medical devices

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point e

(e) to ~~provide advice and assist the Commission, at its request, in its assessment of any issue related to the implementation of this Regulation~~regularly review norms and standards for medical devices;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point f a (new)

(f a) to develop and implement a framework for a European market surveillance programme;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point f b (new)

(f b) to develop minimum requirements for a quality management system for the national market surveillance authorities;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point f c (new)

(f c) to organise a joint market surveillance and joint test projects in the Member States;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point f d (new)

(f d) to organise the sharing of competences between the Member States with regard to market surveillance, notified bodies and clinical evaluations;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point f e (new)

(f e) to organise information campaigns and joint verification programmes;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point f f (new)

(f f) to create the prerequisites that an opinion on a classification request in Annex VII for a specific medical device or groups of medical devices according to Article 41 (3) can be provided within 6 months;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point f g (new)

(f g) to create the prerequisites that an opinion on a request by the Commission regarding the classification of a medical device or groups of medical devices according to Article 41 (4) can be provided;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 80 – paragraph 1 – point f h (new)

(f h) to develop a framework programme for post market surveillance

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 1 – part II – point 9 – point 9.2

9.2. Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body shall comply, by analogy, with the relevant requirements laid down in Annex I to Directive 2001/83/EC.deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 1 – part III – point 19 – point 19.1 – paragraph 1 – point d

(d) Labels shall be provided in a human- readable format ~~but may~~and shall be supplemented by machine-readable forms, such as radio- frequency identification (RFID) or bar codes.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – heading 1

~~MINIMUM~~ REQUIREMENTS TO BE MET BY NOTIFIED BODIES

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 1 – point 1.2 – point 1.2.1

1.2.1. The notified body, including its personnel shall be a third- party body that is independent of the manufacturer of the product in relation to which it performs conformity assessment activities. The notified body shall also be independent of any other economic operator having an interest in the product as well as of any competitor of the manufacturer. This does not preclude any conformity assessment activities for economic operators or competitors, mentioned above.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 1 – point 1.2 – point 1.2.4

1.2.4. The impartiality of the notified bodies, of their top level management ~~and~~, of the assessment personnel and subcontractors shall be guaranteed. The remuneration of the top level management ~~and~~, assessment personnel and subcontractors of a notified body shall not depend on the results of the assessments.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 1 – point 1.5 – paragraph 1

The notified body, including its subsidiaries, shall have at its disposal the financial resources required to conduct its conformity assessment activities and related business operations. It shall document and provide evidence of its financial capacity and its sustainable economic viability, taking into account specific circumstances during an initial start-up phase.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 1 – point 1.6 – point 1.6.1

1.6.1. The notified body shall participate in, or ensure that its assessment personnel ~~is informed~~, including subcontractors, is informed and trained on of the relevant standardisation activities and the activities of the notified body coordination group and that its assessment and decision making personnel are informed of all relevant legislation, standards, guidance and best practice documents adopted in the framework of this Regulation.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 1 – point 1.6 – point 1.6.2

1.6.2. The notified body shall adhere to a code of conduct, addressing among other things, ethical business practices for notified bodies in the field of medical devices that is accepted by the national authorities responsible for notified bodies. The code of conduct shall provide for a mechanism of monitoring and verification of its implementation by notified bodies.deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 2 – point 2.2 – introductory part

2.2. The quality management system of the notified body and its subcontractors shall at least address the following:

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 2 – point 2.2 – indent 8 a (new)

- continuous training.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – introductory part

3.1.1. A notified body and its subcontractors shall be capable of carrying out all the tasks assigned to it by this Regulation with the highest degree of professional integrity and the requisite technical competence in the specific field, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.2

3.1.2. At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a notified body shall have within its organisation the necessary administrative, technical and scientific personnel with technical knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data or the evaluation of an assessment made by a subcontractor..

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.1

3.2.1. The Notified Body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing training). The qualification criteria shall address the various functions within the conformity assessment process (e.g. auditing, product evaluation/testing, design dossier/file review, decision-making) as well as the devices, technologies and areas (e.g. biocompatibility, sterilisation, tissues and cells of human and animal origin, clinical evaluation, risk management) covered by the scope of designation.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.3 – indent 7 a (new)

- adequate seniority / experience in Conformity Assessments under this Regulation or previously applicable directives during a period of at least 3 years within a Notified Body. The Notified Body staff involved in certification decisions shall not have been involved in the Conformity Assessment on which a certification decision needs to be taken.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 – introductory part

3.2.5. Product Specialist: The personnel responsible for carrying out product related review ~~(e.g.~~s design dossier review~~, technical documentation review or type examination including~~ or type examination of class III devices especially aspects such as clinical evaluation, biological safety, sterilisation, software validation) shall have the following proven qualification:

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 a (new)

3.2.5 a. Product Assessor: The personnel responsible for carrying out product related reviews (technical file reviews) or type-examination of class IIa/IIb devices shall have the following proven qualifications: – successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, natural science or engineering; – four years professional experience in the field of healthcare products or related sectors (e.g. industry, audit, healthcare, research experience) whilst two years of this experience shall be in the design, manufacture, testing or use of the device (as defined within a generic device group) or technology to be assessed or related to the scientific aspects to be assessed; – appropriate knowledge of the general safety and performance requirements laid down in Annex I as well as related delegated and/or implementing acts, harmonized standards, CTS and guidance documents; – appropriate knowledge and experience of risk management and related medical device standards and guidance documents; – appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes VIII to X, in particular of those aspects for which they are authorized, and adequate authority to carry out those assessments.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 – indent 2

– four years professional experience in the field of healthcare products or related sectors (e.g. industry, audit, healthcare, research experience) whilst two years of this experience shall be in the design, manufacture, testing or use of the device (as defined within a generic device group) or technology to be assessed or related to the scientific aspects to be assessed;

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 – indent 3 a (new)

- In addition, qualification is based on technical or scientific specialisms e.g. sterilization, biocompatibility, animal tissue, human tissue, software, functional safety, clinical evaluation, electrical safety, packaging;

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.6 – introductory part

3.2.6. Auditor: The personnel responsible for carrying out audits of the manufacturer's quality ~~management~~assurance system shall have the following proven qualification:

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.6 – indent 2 a (new)

- qualification shall be based on technology as defined by IAF / EAC coding or equivalent;

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 3 – point 3.4 – point 3.4.3

3.4.3. Where subcontractors or external experts are used in the context of the conformity assessment, in particular regarding novel, invasive and implantable medical devices or technologies, the notified body shall have adequate own competence in each product area, each treatment or medical speciality for which it is designated to lead the conformity assessment, to verify the appropriateness and validity of expert opinions and make the decision on the certification.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 6 – point 4 a (new)

4 a. Minimum time for Notified Body audit assessments – Notified bodies shall identify the audit duration for the stage 1 and stage 2 initial audits, and surveillance audits for each applicant and certified client – The effective number of personnel at the manufacturer including all individual manufacturing facilities covered by the certificate is used as a basis for calculation of audit duration – It is appropriate to base audit duration on the effective number of personnel of the organization, the complexity of the processes within the organization, the nature and the characteristics of the medical devices included in the scope of the audit and the different technologies that are employed to manufacture and control the medical devices. The audit duration should be adjusted based on any significant factors that uniquely apply to the organization to be audited. The notified body should exercise discretion to ensure that any variation in audit duration does not lead to a compromise on the effectiveness of audits – The duration of any scheduled on site audit cannot be less than one auditor/day. – Certification of multiple sites under one quality assurance system cannot be based on a sampling system.

2013/05/14
Committee: ENVI

Anja WEISGERBER, Holger KRAHMER

Proposal for a regulation
Annex 7 – part III – point 6 – point 6.7 – paragraph 1

All devices incorporating or consisting of nanomaterial ~~are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user's body when the device is used within its intended purpose~~deliberately intended to be released into the body are in class III.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 7 – part III – point 6 – point 6.8

~~6.8. Rule 20 All devices intended to be used for aphaeresis, such as aphaeresis machines, sets, connectors and solutions, are in class III.~~deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 8 – point 3 – point 3.2 – introductory part

3.2. Application of the quality management system shall ensure that the devices conform to the provisions of this Regulation which apply to them at every stage, from design to final inspection and delivery. All the elements, requirements and provisions adopted by the manufacturer for his quality management system shall be documented in a systematic and orderly manner in the form of written policies and procedures such as quality programmes, quality plans, quality manuals and quality records.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 8 – point 4 – point 4.3

4.3. The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan, and shall supply the manufacturer with an assessment report. This shall include inspections on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. At the time of such inspections, the notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with an inspection report and, if a test has been carried out, with a test report.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 8 – point 4 – point 4.3

4.3. The notified body shall ~~periodically, at least once every 12 months~~once a year, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality ~~management~~assurance system and the post-market surveillance plan, and shall supply the manufacturer with an assessment report. This shall include inspections on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. At the time of such inspections, the notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with an inspection report and, if a test has been carried out, with a test report.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 8 – point 4 – point 4.4 – introductory part

4.4. The notified body shall randomly perform - at least once in 5 years and for each manufacturer and generic device group - unannounced ~~factory~~ inspections ato the relevant manufacturering sites and, if appropriate, ofat the manufacturer's suppliers and/or subcontractors~~, which may be combined with the periodic surveillance assessment referred to~~. The notified body shall establish a plan for the unannounced in Sspection ~~4.3. or be performed in addition to this surveillance assessment. The notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer~~s which must not be disclosed to the manufacturer. At the time of such unannounced inspections, the notified body shall carry out or ask for tests in order to check that the quality assurance system is working properly. It shall provide the manufacturer with an inspection report.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 8 – point 4 – point 4.4 – introductory part

4.4. The notified body shall randomly perform unannounced ~~factory~~ inspections tof the ~~manufacturer~~relevant production plants and, if appropriate, of the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 4.3. or be performed in addition to this surveillance assessment. The notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer. at least every 5 years and for each manufacturer and each specific product group. The notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer. In these unannounced inspections, the notified body shall check whether the quality management system is working properly or shall arrange for such checks to be performed. The notified body shall provide the manufacturer with an inspection report.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 8 – point 4 – point 4.4 – paragraph 2

In~~stead of, or in~~ addition to, the sampling from the production, the notified body shall if possible itself take samples of devices from the market ~~to verify that the manufactured device is in conformity with the technical documentation and/or design dossier~~or otherwise arrange for this to be done by external market surveillance authorities. Checks on whether the manufactured device is in conformity with the technical documentation and/or design dossier must be performed at least once within five years for each manufacturer and each specific product group. Prior to the sampling, the notified body shall specify the relevant sampling criteria and testing procedure. The taking of the sample and its examination shall be performed at the manufacturer’s expense.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 8 – point 4 – point 4.5 – paragraph 1

In the case of devices classified as class III, the surveillance assessment shall also include a check of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, the coherence between the quantities of produced or purchased parts and/or materials and the quantities of finished products.deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 8 – point 4 – point 4.6

4.6. The notified body shall ensure that the composition of the assessment team assures experience with the technology concerned, continuous objectivity and neutrality~~; this shall include a rotation of the members of the assessment team at appropriate intervals. As a general rule, a~~. A lead auditor shall not lead and attend an audit for more than ~~thre~~five consecutive years in respect to the same manufacturer.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 8 – point 8 – introductory part

8. The manufacturer or his authorised representative shall, for a period ~~ending~~ at least ~~five years, and in the case of implantable devices at least~~equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than 150 years~~, after the last device has been placed on the market~~ from the date of product release by the manufacturer, keep at the disposal of the competent authorities:

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 9 – point 7 – paragraph 1 – introductory part

The manufacturer or his authorised representative shall, for a period ~~ending~~ at least ~~five years, and in the case of implantable devices at least~~equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than 150 years~~, after the last device has been placed on the market~~ from the date of product release by the manufacturer, keep at the disposal of the competent authorities:

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – point 4 – paragraph 2

In the case of devices classified as class III, the surveillance shall also include a check of the coherence between the quantity of produced or purchased raw material or crucial components approved for the type and the quantity of finished products.deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – point 6 – paragraph 1 – introductory part

The manufacturer or his authorised representative shall, for a period ~~ending~~ at least ~~five years, and in the case of implantable devices at least~~equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than 150 years~~, after the last device has been placed on the market~~ from the date of product release by the manufacturer, keep at the disposal of the competent authorities:

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – point 7 – point 7.5 – introductory part

7.5. By way of derogation from Section 6, the manufacturer or his authorised representative shall, for a period ~~ending~~ at least ~~five years after the last~~equivalent to the lifetime of the medical device has ~~been placed on the market~~defined by the manufacturer, but not less than 10 years from the date of product release by the manufacturer, keep at the disposal of the competent authorities:

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – heading 3 – Part B

Part B: EU Product verification

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – Part B – point 4 – introductory part

4. The notified body shall carry out the appropriate examinations and tests in order to ~~verify~~assess the conformity of the device with the requirements of the Regulation by examining and testing every product as specified in Section 5 or by examination and testing of the products on a statistical basis as specified in section 6.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – Part B – point 5 a (new)

5 a. Statistical verification of conformity

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – Part B – point 5 a – part 5.1 (new)

5.1. The manufacturer shall present the manufactured products in the form of homogeneous batches. The proof of homogeneity for the presented products shall be part of the batch documentation.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – Part B – point 5 a - part 5.2 (new)

5.2. A random sample is taken from each batch. The products which make up the sample shall be examined individually and the appropriate physical or laboratory tests defined in the relevant standard(s) referred to in Article 6 or equivalent tests shall be carried out in order to verify the conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – Part B – point 5 a – part 5.3 (new)

5.3. Statistical control of products shall be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonized standards or equivalent tests referred to in Article 6, taking account of the specific nature of the product categories in question.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – Part B – point 5 a – part 5.4 (new)

5.4. The notified body shall affix, or have affixed, its identification number to each approved device and shall draw up an EU product verification certificate relating to the tests carried out. All products in the batch may be put on the market except any in the sample which failed to conform. If a batch is rejected, the competent notified body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the notified body may suspend the statistical verification.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – Part B – point 7 – paragraph 1 – introductory part

The manufacturer or his authorised representative shall, for a period ~~ending~~ at least ~~five years, and in the case of implantable devices at least~~equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than 150 years~~, after the last device has been placed on the market~~ from the date of product release by the manufacturer, keep at the disposal of the competent authorities:

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 10 – Part B – point 8 – point 8.4 – introductory part

8.4. By way of derogation from Section 7, the manufacturer or his authorised representative shall, for a period ~~ending~~ at least ~~five years after the last~~equivalent to the lifetime of the medical device has ~~been placed on the market~~defined by the manufacturer, but not less than 10 years from the date of product release by the manufacturer, keep at the disposal of the competent authorities:

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 13 – point 5

5. In the case of implantable devices ~~and devices falling within class III~~, clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone. Demonstration of equivalence in accordance with Section 4 shall generally not be considered as sufficient justification within the meaning of the first sentence of this paragraph.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 13 – point 3

3. The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the technical documentation. For implantable medical devices, the manufacturer's PMCF evaluation report shall be reviewed by an independent scientific body, such as an academic institution or a medical society. In order to conduct its review, the manufacturer shall provide the relevant data to the independent scientific body. Both the manufacturer's PMCF evaluation report and its review by an independent scientific body shall be part of the technical documentation for class III medical devices.

2013/05/14
Committee: ENVI