BETA

41 Amendments of Andreas SCHWAB related to 2012/0266(COD)

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 Treaty on the Functioning of the European Union should be delegated to the Commission in respect 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 ~~investigation~~performance studies; 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 ~~investigation~~performance studies; 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. However, substantial elements of this Regulation such as general safety and performance requirements, elements to be addressed in technical documentation, the minimum content of the EU declaration of conformity, amending or supplementing the conformity assessment procedures, should only be amended through the ordinary legislative procedure. 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.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4 – introductory part

(4) ‘active device’ means any device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or by gravity and which acts by changing the density of or converting this energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be considered to be active devices.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4 – paragraph 1

~~Stand alone software shall be considered an active device;~~deleted

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 31 a (new)

(31a) ‘safety’ means the absence or avoidance of unacceptable risks for the patient or user;

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 40 – introductory part

(40) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, ~~use errors~~ or inadequacy in the information supplied by the manufacturer;

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 4 – paragraph 5

~~5. The Commission shall be empowered to adopt~~ delegated acts in accordance with Article 89 amending or supplementing, in the light of technical progress and considering the intended users or patients, the general safety and performance requirements set out in Annex I, including the information supplied by the manufacturer.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2

~~The Commission shall be empowered to adopt~~ delegated ~~acts in accordance with Article 89 amending or supplementing, in the light of technical progress, the elements in the technical documentation set out in Annex II.~~

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 16 – paragraph 1

1. The manufacturer of an implantable ~~device shall provid~~, sterile-packaged device shall make available in advance toge the~~r with the device an implant card which shall be made available~~ healthcare professional or where relevant, to the particular patient who ~~has been~~is going to be implanted with the device, the information to be included in an implant passport or in an implant card.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 b (new)

The following implants are excluded from this obligation: sutures, staples, dental implants, screws, plates and accessories to orthopaedic implants.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 c (new)

The Commission shall, by means of implementing acts, regularly update the list of implantable devices which do not have to fulfil this obligation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 17 – paragraph 1

1. The EU declaration of conformity shall state that fulfilment of the requirements specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall be ~~translated into th~~available in one official Union language ~~or languages required by the Member State(s) in which the device is made available~~.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 17 – paragraph 4

~~4. The Commission shall be empowered to adopt~~ delegated ~~acts in accordance with Article 89 amending or supplementing the minimum content of the EU declaration of conformity set out in Annex III in the light of technical progress.~~

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 21 – paragraph 1

1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without ~~significantly~~ changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. Substantiating evidence shall be kept available to the competent authorities of the Member States.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 21 – paragraph 2

2. An article that is intended specifically to replace a part or component of a device and that ~~significantly~~ changes the performance or safety characteristics of the device shall be considered as a device and shall meet the requirements laid down in this Regulation.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 21 – paragraph 2 a (new)

2a. Any natural or legal person who refurbishes a device according to the provisions formally laid down by the manufacturer of the device shall ensure that the refurbishment does not adversely affect the safety and performance.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 21 – paragraph 2 b (new)

2b. Any natural or legal person who refurbishes a device either in the absence of provisions formally laid down by the manufacturer of the device or disregarding or violating such provisions to make it suitable for further use within the Union shall be considered to be the manufacturer of the refurbished device and shall assume the obligations incumbent on manufacturers as laid down in this Regulation.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 25 – paragraph 1

1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information that is necessary and proportionate to describe and identify the device and to identify the manufacturer and, where applicable, the authorised representative and the importer. The details regarding the information to be submitted by the economic operators are laid down in Part A of Annex V. The Commission shall decide on one common language as a generally binding language for the registration.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 25 – paragraph 2

2. Before a device, other than a custom- made or investigational device, is placed on the market the manufacturer or his authorised representative shall submit to the electronic system the information referred to in paragraph 1. It shall be ensured that besides the European registration no national registrations in individual Member States can additionally be required.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 33 – paragraph 2

2. Member States may notify only conformity assessment bodies which satisfy the requirements set out in Annex VI and which have successfully passed an initial assessment performed by the joint assessment team according to Article 32(3) and have been awarded a positive recommendation by the MDCG according to Article 44a.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 35 – paragraph 4

4. T~~hree~~wo years after notification of a notified body, and again every ~~thir~~second year thereafter, the assessment to determine whether the notified body still satisfies the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established 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 ongoing compliance of a notified body with the requirements set out in Annex VI.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 41 – paragraph 2 – subparagraph 2

At least 14 days prior to any decision, the competent authority shall notify the MDCG and the Commission of its envisaged decision. The final decision shall be made publically available in the Eudamed.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 41 – paragraph 3 – subparagraph 1

3. The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices, with a view to determining their classification. Such decision should in particular be taken in order to resolve diverging decisions between Member States.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 42 – paragraph 10 a (new)

10a. Unannounced inspections, in terms of their nature and extent, may be counted as regular inspections, with offsetting of economic operators’ costs resulting from unannounced inspections, provided that no significant non- conformities are recorded during unannounced inspections. Account must be taken at all times, when ordering unannounced inspections and carrying them out, of the proportionality principle, with due regard, in particular, for the risk potential of each individual product.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 42 – paragraph 11

11. In the light of technical progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 28 to 40, or of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the conformity assessment procedures set out in Annexes VIII to XI.deleted

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 44

Mechanism for scrutiny of certain 1. Notified bodies shall notify the Commission of applications conformity assessments for devices classified as class III, with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG. 2. Within 28 days of receipt of the information referred to in paragraph 1, the MDCG may request the notified body to submit a summary of the preliminary conformity assessment prior to issuing a certificate. Upon suggestion by any of its members or by the Commission, the MDCG shall decide on making such request in accordance with the procedure set out in Article 78(4). In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file for submission of a summary of the preliminary conformity assessment. When selecting a specific file for submission, the principle of equal treatment shall be duly taken into account. Within 5 days after receipt of the request by the MDCG, the notified body shall inform the manufacturer thereof. 3. The MDCG may submit comments on the summary of the preliminary conformity assessment at the latest 60 days after submission of this summary. Within that period and at the latest 30 days after submission, the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the notified body’s preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer’s premises. submission of the additional information requested, the period for comments referred to in the first sentence of this subparagraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments. 4. The notified body shall give due consideration to any comments received in accordance with paragraph 3. It shall convey to the Commission an explanation of how they have been taken into consideration, including justification for not following the comments received, and its final decision regarding the conformity assessment in question. The Commission immediately transmit this information to the MDCG. 5. Where deemed necessary for the protection of patient safety and public health, the Commission, may determine, by means of implementing acts, specific categories or groups of devices, other than devices of class III, to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). Measures pursuant to this paragraph may be justified only by one or more of the following criteria: (a) the novelty of the device or of the technology on which it is based and the significant clinical or public health impact thereof; (b) an adverse change in the risk-benefit profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in case of failure; (c) an increased rate of serious incidents reported in accordance with Article 61 in respect of a specific category or group of devices; (d) significant discrepancies in the conformity assessments carried out by different notified bodies on substantially similar devices; (e) public health concerns regarding a specific category or group of devices or the technology on which they are based. 6. The Commission shall make a summary of the comments submitted in accordance with paragraph 3 and the outcome of the conformity assessment procedure accessible to the public. It shall not disclose any personal data or information of commercially confidential nature. 7. The Commission shall set up the technical infrastructure for the data- exchange by an electronic means between notified bodies and MDCG for the purposes of this Article. 8. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment in accordance with paragraphs 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).Article 44 deleted conformity assessments for Until any due shall

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 44 a (new)

Article 44a Scrutiny of notified bodies and national competent authorities responsible for notified bodies 1. The MDCG shall ensure alignment of the initial assessment, qualification, notification and surveillance of notified bodies, and alignment of the notification and surveillance activities of national competent authorities responsible for notified bodies. 2. In order to achieve the objective established in paragraph 1 on the alignment with regard to the national competent authorities responsible for notified bodies, the MDCG shall establish detailed rules for peer-reviews of national authorities responsible for notified bodies according to Article 28(8). These rules shall be mandatorily applied to all peer- reviews which shall be performed every two years by national competent authorities responsible for notified bodies according to the annual plan for peer- reviews according to Article 28(8). 3. Members of the MDCG shall participate in the peer-reviews of the national competent authorities responsible for notified bodies according to Article 28(8). 4. The MDCG shall establish detailed requirements on the qualification of its audit experts for participation in peer- reviews according to Article 28(8). 5. In order to achieve the objective established in paragraph 1 on the alignment with regard to the notified bodies, the MDCG shall have experts who are qualified in the assessment of conformity assessment bodies and notified bodies. At least two such experts shall participate in the joint assessment teams for the assessment of conformity assessment bodies according to Article 32(3) and of notified bodies according to Article 35(4). 6. In order to achieve the objective established in paragraph 1 on the alignment with regard to the notified bodies, the MDCG shall establish detailed qualification requirements on its experts for the assessment of conformity assessment bodies and of notified bodies. 7. The MDCG shall review the opinion provided by the joint assessment team regarding the assessment report and the draft notification according to Article. 32(6), 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. 8. As a further measure to achieve the objective established in paragraph 1 on the alignment with regard to the notified bodies, the MDCG shall establish detailed harmonized rules which shall mandatorily be applied to the assessments of conformity assessment bodies and their notifications as notified bodies. These rules shall comprise: (a) Prerequisites for assessment and notification as a notified body including - requirements on its organisation, quality management system, processes; - requirements on necessary resources, including qualification and training; - specific requirements on auditors and technical assessors of notified bodies; - specific requirements on test laboratories incl. subcontractors; - particular attention shall be paid to sterilisation processes, biocompatibility, devices containing tissues and cells of human and animal origin, clinical evaluation; - requirements on independency, impartiality and confidentiality. (b) Detailed rules for initial assessments and surveillance assessments: - surveillance assessments shall be performed on a regular basis, at least annually. - surveillance assessments shall be performed on-site and cover the assessment of quality management certifications, of type examinations and design dossier examinations, clinical evaluations and post market surveillance plans; specific focus shall be put on Class III devices and novel devices. (c) Rules and criteria for surveillance assessments due to reasonable suspicion; such assessments shall be performed primarily unannounced; (d) Rules for the restriction or withdrawal of notifications; (e) 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.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 62 – paragraph 2

2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission ~~and~~, to the notified bodies and to manufacturers relating to information about their own devices.

2013/05/17
Committee: IMCO

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

5a. It shall be ensured that besides the European reporting no national reporting in individual Members States can additionally be required.

2013/05/17
Committee: IMCO

Proposal for a regulation
Article 67 – paragraph 1 a (new)

1a. Unannounced inspections, in terms of their nature and extent, may be counted as regular inspections, with offsetting of economic operators’ costs resulting from unannounced inspections, provided that no significant non-conformities are recorded during unannounced inspections. Account must be taken at all times, when ordering unannounced inspections and carrying them out, of the proportionality principle, with due regard, in particular, for the risk potential of each individual product.

2013/05/17
Committee: IMCO

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

9. Devices incorporating a substance considered to be a medicinal product ~~and devices composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally~~.

2013/05/17
Committee: IMCO

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

2013/05/17
Committee: IMCO

Proposal for a regulation
Annex 4 – point 1 – introductory part

1. The CE marking shall consist of the initials ‘CE’ accompanied by the term "Medical Device" taking the following form:

2013/05/17
Committee: IMCO

Proposal for a regulation
Annex 7 – part III – point 4 – point 4.2 – paragraph 1 – indent 1

– are ~~intended~~active or implantable devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in class III,

2013/05/17
Committee: IMCO

Proposal for a regulation
Annex 7 – part III – point 4 – point 4.2 – paragraph 1 – indent 3

– are ~~intended specifically for use in direct contact with the central nervous system~~active or implantable devices intended specifically to control, diagnose, monitor or correct a defect of the central nervous system through direct contact with these parts of the body, in which case they are in class III,

2013/05/17
Committee: IMCO

Proposal for a regulation
Annex 7 – part III – point 4 – point 4.3 – paragraph 1 – indent 1

– are active or implantable devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in class III,

2013/05/17
Committee: IMCO

Proposal for a regulation
Annex 7 – part III – point 4 – point 4.3 – paragraph 1 – indent 2

– are active or implantable devices intended specifically for use in direct contact with the central nervous system, in which case they are in class III,

2013/05/17
Committee: IMCO

Proposal for a regulation
Annex 7 – part III – point 4 – point 4.4 – paragraph 1 – indent 8

– are spinal disc replacement implants ~~and implantable devices that come into contact with the spinal column~~, in which case they are in class III.

2013/05/17
Committee: IMCO

Proposal for a regulation
Annex 7 – part III – point 5 – point 5.1 – paragraph 3 a (new)

Stand alone software shall be considered an active device.

2013/05/17
Committee: IMCO

Proposal for a regulation
Annex 7 – part III – point 6 – point 6.1 – paragraph 1

All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive ~~2001/83~~65/65/EEC, ~~including a medicinal product derived from human blood or human plasma,~~and which is liable to act on the human body with action ancillary to that of the devices, are in class III.

2013/05/17
Committee: IMCO

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~~intended to be intentionally released into the ~~patient’s or user’s body when the device is used within its intended purpose~~human body are classified as class III.

2013/05/17
Committee: IMCO

Proposal for a regulation
Annex 13 – part A – 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. DFor novel products, 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. However, for iteration of devices already on the market and for which clinical data are available and for which the data from the post-market surveillance are not indicating any safety concerns, demonstration of equivalence may be considered as a sufficient justification. For devices submitted to the scientific assessment foreseen in this Regulation, demonstration of equivalence shall be assessed by the MDCG.

2013/05/17
Committee: IMCO