Activities of Thomas ULMER related to 2012/0266(COD)

Proposal for a regulation
Recital 12 a (new)

(12a) Devices for use in blood donation and blood therapy should meet the requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC.

2013/05/14
Committee: ENVI

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. However, basic aspects of this Regulation such as general safety and performance requirements, stipulations on technical documentation and the requirements for CE mark certification, as well as any amendments or additions to it, should be provided for only 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.

2013/05/14
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 principal action by pharmacological, immunological or metabolic means;

2013/05/14
Committee: ENVI

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.

2013/05/14
Committee: ENVI

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

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

2013/05/14
Committee: ENVI

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

(31a) ‘safety’ means the absence or elimination of unacceptable risks to patients or users.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 33

(33) ‘clinical investigation’ means any systematic investigation in one or more human subjects, undertaken to assess the safety or, performance or effectiveness of a device;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 37

(37) ‘sponsor’ means an individual, company, institution or organisation which takes responsibility for the initiation ~~and~~, management and direction and/or financing of a clinical investigation;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 37 a (new)

(37a) ‘conformity assessment’ of a clinical study means the checking by the authorities responsible of the relevant official documentation, facilities and records and of the existence of sufficient insurance cover. Such checking may be carried out on the premises of the sponsor and/or the research establishment or wherever the authority responsible may deem checks to be necessary.

2013/05/14
Committee: ENVI

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;

2013/05/14
Committee: ENVI

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.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 7 – paragraph 1 a (new)

1a. It should be possible for the Commission, if such necessary standards do not exist or if competent bodies or specialists have highlighted shortcomings in them, to delegate to specialists the task of proposing amendments in this specific area. These would then be incorporated into this Regulation in the form of implementing acts.

2013/05/14
Committee: ENVI

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.~~

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 2

Where the technical documentation is voluminous or held in different locations, the manufacturer shall provide, upon request by a competent authority, a summary technical documentation (STED) and grant access to the full technical documentation upon request.deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 1

Proportionate to the risk class and the type of device, manufacturers of devices, other than custom-made devices, shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service and to apply any necessary corrective action, hereinafter referred to as ‘post-market surveillance plan’. The post- market surveillance plan shall set out the process for collecting, recording and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, keeping a register of non-conforming products and product recalls or withdrawals, and if deemed appropriate due to the nature of the device, sample testing of marketed devices. Part of the post-market surveillance plan shall be a plan for post-market clinical follow-up in accordance with Part B of Annex XIII. The analysis and reporting of clinical follow- up should include reference to independent organisations. Where post- market clinical follow-up is not deemed necessary, this shall be duly justified and documented in the post- market surveillance plan.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 8 – paragraph 9

9. Manufacturers shall, in response to a reasoned request from a competent authority, a recognised medical institution or an association organised at European level, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part

Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:

2013/05/14
Committee: ENVI

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

(b) in the absence of a manufacturer’s or importer’s declaration of conformity, the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);

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~~11(3).

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, within their field of operations, that 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 – paragraph 1 – subparagraph 1 – introductory part

Manufacturers shall have available within their organisation at least one qualified person who possesses ~~expert knowledg~~the requisite expertise in the field of medical devices. The ~~expert knowledg~~requisite expertise shall be demonstrated by either of the following qualifications:

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 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;in natural sciences, medicine or technology, or

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 1 – point b

(b) ~~five years of professional experience in regulatory affairs or in quality management systems relating to medical devices~~an educational qualification attesting to competence to perform the tasks listed in paragraph 2 and at least two years’ professional experience. Proof of expertise must be supplied on request to the authorities responsible.

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 ~~knowledg~~ise referred to in the first s~~ubparagraph~~entence by at least two years of professional experience within the relevant field of manufacture.

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~~reporting obligations in accordance with Articles 61 to 66 are fulfilled;

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 point 4.1 of Chapter II of Annex XIV is issued.~~deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 2 – subparagraph 1 (new)

If a number of qualified persons are jointly responsible in respect of the provision in the first sentence, their respective areas of responsibility shall be stipulated in writing.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 15 – paragraph 1

1. Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation. Hospitals that reprocess single-use devices in house shall not be deemed to be manufacturers. They must, however, demonstrate that they have the requisite technical expertise for in-house reprocessing and must possess liability insurance covering them in the event of problems with the reprocessing.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 15 – paragraph 3

3. In the case of reprocessing of single-use devices for critical use, only reprocessing that is considered safe according to the latest scientific evidence may be carried out; the hygiene requirements for the reprocessing of medical devices recommended by the Commission for Hospital Hygiene and the Prevention of Infection (KRINKO), attached to the Robert Koch Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) should serve as examples of practice in this regard.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 16 – paragraph 1

1. The manufacturer of an implantable device ~~shall provide~~in sterile packaging shall provide in advance to the relevant health professional, together with the device, an implant card which shall be made available to the particular patient who has been implanted with the device. The implanter shall be responsible for making the card available to the patient and entering the data in the relevant database. The following types of implant shall be exempt: stitches, clips, screws, plates and accessories to orthopaedic implants. The Commission, by means of implementing acts, shall regularly review and update this list of exempted implants. Those implementing acts shall be adopted in accordance with Article 88(3).

2013/05/14
Committee: ENVI

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 the~~issued in an EU official Union language ~~or languages~~ required by the Member State(s) in which the device is ~~made available~~placed on the market, and also in English if the device is made available in other Member States.

2013/05/14
Committee: ENVI

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.~~

2013/05/14
Committee: ENVI

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 must meet the requirements laid down in this Regulation.

2013/05/14
Committee: ENVI

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

2a. Any natural or legal person who reprocesses a device in accordance with the manufacturer’s recommendations must ensure that he does not adversely affect the characteristics or the safety of the device.

2013/05/14
Committee: ENVI

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

2b. Any natural or legal person who reprocesses a device without reference to the manufacturer’s recommendations on reprocessing or who disregards or violates those recommendations shall be considered as a manufacturer within the meaning of this Regulation.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 24 – paragraph 1 – introductory part

1. For class II devices, other than custom- made and investigational devices, a system for Unique Device Identification shall be put in place in the Union. The UDI system shall allow the identification and traceability of devices and shall consist of the following:

2013/05/14
Committee: ENVI

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

(ea) compatibility with identification systems for medical devices already on the market.

2013/05/14
Committee: ENVI

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. Steps shall be taken to ensure that no additional national registration procedures are necessary.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 25 – paragraph 5

5. Not later than ~~two~~five years after submission of the information in accordance with paragraphs 2 and 3, and then every ~~second~~fifth year, the relevant economic operator shall confirm the accuracy of the data. In the event of failure to confirm within six months of the due date, any Member State may take measures to suspend or otherwise restrict the making available of the device in question within its territory until the obligation referred to in this paragraph is complied with.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 1

1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a ~~summary~~report ofn safety and clinical performance which sets out the results of the clinical studies and trials. It shall be written in a way that is clear to the intended user. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 1 a (new)

1a. Doctors and healthcare professionals should have access to all areas of Eudamed.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 1 b (new)

1b. the data submitted shall be checked and assessed by Eudamed before being made available.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 1 – point a

(a) to enable the public to be adequately informed about devices placed on the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators, with the proviso that manufacturers must be able to maintain commercial confidentiality on this highly innovative market;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 4

4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors, healthcare professionals and the public to the extent defined in the provisions referred to in paragraph 2.

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 notify only conformity assessment bodies which satisfy the requirements set out in Annex VI and the requirements laid down by the joint assessment team, as provided for in Article 32(3), and which have received a positive assessment from the MDCG (Article 44 a (new)).

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 40 – paragraph 1

1. The Member State where the bodies are established shall ~~levy~~collect fees onfrom applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation. The Commission shall set the level of the fees. These shall be standard fees which are collected in all the Member States in the same way.

2013/05/14
Committee: ENVI

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 available in the European Database.

2013/05/14
Committee: ENVI

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

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. Decisions of this kind shall primarily be taken in order to ensure that Member States do not apply differing classification criteria to a given device or category or group of devices.

2013/05/14
Committee: ENVI

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

2013/05/14
Committee: ENVI

Thomas ULMER, Richard SEEBER

Proposal for a regulation
Article 44

~~[...]~~deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 44 a (new)

Article 44a Inspection procedure for notified bodies national authorities responsible for notified bodies 1. The MDCG shall be responsible for standardising the procedures for the initial assessment, notification and monitoring of notified bodies and the notification and monitoring activities of the national authorities responsible for notified bodies. 2. With a view to achieving the objectives referred to in paragraph 1 concerning the standardisation of the work of national authorities responsible for notified bodies, the MDCG shall introduce clear rules on the peer review of national authorities responsible for notified bodies, in accordance with Article 28(8). These rules must be binding for all peer reviews, which shall be carried out every two years by the national authorities responsible for notified bodies in accordance with the annual plan laid down in Article 28(8). 3. Members of the MDCG shall take part in this peer review of national authorities responsible for notified bodies carried out in accordance with Article 28(8). 4. The MDCG shall lay down detailed requirements to be met by the audit experts who carry out the peer review of national authorities responsible for notified bodies in accordance with Article 28(8). 5. With a view to achieving the objectives referred to in paragraph 1 concerning the standardisation of the work of notified bodies, the MDCG shall include experts in the work of conformity assessment bodies and notified bodies. At least two such experts shall be included in the joint assessment team referred to in Article 32(3) set up to monitor the conformity assessment bodies and notified bodies in accordance with Article 35(4). 6. With a view to achieving the objectives referred to in paragraph 1 concerning the standardisation of the work of notified bodies, the MDCG shall lay down detailed requirements as regards the qualifications of the experts responsible for monitoring the work of conformity assessment bodies and notified bodies. 7. The MDCG shall consider the opinion concerning the assessment report and the draft notification drawn up by the joint assessment team pursuant to Article 32(6) and shall decide whether to issue a positive or negative recommendation. This recommendation shall be forwarded to the Commission and the national authorities responsible for notified bodies. 8. Likewise with a view to achieving the objective referred to in paragraph 1, the MDCG shall develop detailed, binding rules for the assessment of conformity assessment bodies and notified bodies. These rules shall incorporate: (a) criteria governing the assessment and notification of notified bodies: - requirements concerning their organisation, quality and management systems and processes; - requirements concerning the requisite resources, including the qualifications and specialist training of their staff; - specific requirements to be met by the auditors and technical assessors who work for notified bodies; - specific requirements to be net by laboratories and subcontractors; - requirements as regards independence, objectivity and discretion. b) Detailed rules governing initial assessments and follow-up assessments: - follow-up assessments shall be carried out regularly, and at least once a year; - follow-up assessments shall be carried out on the spot and cover an assessment of the quality management certificates, type monitoring and design dossier, clinical tests and post-introduction market monitoring, with a special focus on Class III devices and new devices. c) rules and criteria for follow-up assessments carried out on the basis of substantiated concerns; such assessments shall if at all possible be conducted unannounced; d) rules governing the qualification and withdrawal of decisions; e) rules governing an arbitration procedure in the event of disagreement on a negative recommendation in respect of an initial assessment or the qualification or withdrawal of a decision.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 47 – paragraph 1

1. By way of derogation from Article 42, any competent authority may authorise, on duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in Article 42 have not been carried out and use of which is in the interest of public health or patient safety, provided that the Medical Device Coordination Group has authorised it. This derogation shall be possible only if the manufacturer submits the requisite clinical data to the competent authority within the prescribed period.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 50 – paragraph 1 – point a

(a) to verify that, under normal conditions of use, devices are designed, manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of a medical device referred to in number (1) of Article 2(1), and achieve the performances intended as specified by the manufacturer or sponsor;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 50 – paragraph 1 – point b

(b) to verify that devices achieve the intended benefits to the patient as specified by the manufacturer or sponsor;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 50 – paragraph 3

3. Clinical investigations shall be designed and conducted in a way that the rights, safety and well-being of the subjects participating in a clinical investigation are protected and that the clinical data generated in the clinical investigation are going to be reliable and robust. Clinical investigations shall not be conducted if the associated risks exceed the possible benefit to be derived from the medical device. Member States should have the option of prohibiting clinical investigations of certain product groups or test fields or demanding that certain conditions be complied with.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 51 – paragraph 2 – subparagraph 1

The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the investigation is to be conducted accompanied by the documentation referred to in Chapter II of Annex XIV. Within ~~six~~14 days after receipt of the application, the Member State concerned shall notify the sponsor whether the clinical ~~investigation~~performance study falls within the scope of this Regulation and whether the application is complete.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 51 – paragraph 3 – subparagraph 3

Where the Member State has not notified the sponsor according to paragraph 2 within ~~three~~six days following receipt of the comments or of the completed application, the clinical investigation shall be considered as falling within the scope of this Regulation and the application shall be considered complete.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 51 – paragraph 5 a (new)

5a. Member States shall ensure that they interrupt, terminate or suspend a clinical investigation if new scientific findings are available and the competent authority therefore would no longer authorise the clinical investigation or if the ethics committee would no longer authorise it.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 51 – paragraph 5 – point a

(a) ~~in the case of investigational devices classified as class III and implantable or long-term invasive devices classified as class IIa or IIb,~~ as soon as the Member State concerned has notified the sponsor of its approval;

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 51 – paragraph 5 – point b

(b) in the case of investigational devices other than those referred to in point (a) immediately after the date of application provided that the Member State concerned has so decided and that evidence is provided that the rights, safety and well- being of the subjects to the clinical investigation are protected;deleted

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 51 – paragraph 5 – point c

(c) after the expiry of 3560 days after the validation date referred to in paragraph 4, unless the Member State concerned has notified the sponsor within that period of its refusal based on considerations of public health, patient safety or public policy.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 51 a (new)

Ethics committee A clinical investigation may only be authorised if an independent ethics committee has delivered a positive assessment of the investigation. The statement by the ethics committee should take into account medical feasibility, the consent of the subjects after they have received full information about the possible risks and dangers associated with the clinical investigation, and the suitability of the investigating establishments and of the investigators. The ethics committee has the purpose of protecting the rights, welfare and safety of subjects, users and third parties. The committee must be independent of the research, the sponsor and any other influence. Both national and international standards must be complied with. The ethics committee shall be composed of an adequate number of suitably qualified members. The ethics committee shall, however, also include representatives of civil society.

2013/05/14
Committee: ENVI

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 also to manufacturers where the information pertains to their own product.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 62 – paragraph 3

3. The Commission shall ensure that healthcare professionals have full access to the electronic system and that the public have an appropriate levels of access to it~~he electronic system~~.

2013/05/14
Committee: ENVI

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

5a. No additional national notification system should be established: instead, only the European notification system should apply.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 64 – paragraph 1 a (new)

Medical devices which fall under legal acts of the European Union concerning the quality and safety of blood 1. This Regulation shall not [sic: verb apparently omitted - translator’s note] existing and implemented provisions at European level relating to the collection, testing, processing, storage and distribution of blood and blood components. 2. Medical devices for the collection, testing, processing, storage and distribution of blood and blood components are dealt with mainly under European Union Directive 2002/98 and the standards adopted by the Council on 27 January 2003 for quality and safety in connection with collection, testing, processing, storage and distribution. 3. Measures relating to traceability and vigilance in the field of blood and blood components are of a higher standard than is the case in this Regulation. They should be retained in the interests of patients.

2013/05/14
Committee: ENVI

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

1a. The nature and extent of unannounced inspections, and costs incurred by the economic operator as a result of unannounced inspections, may be credited against regular inspections provided that no significant shortcomings are identified during the inspection. The organisation and implementation of unannounced inspections must always take account of the principle of proportionality, particularly with reference to the hazard potential of a particular product.

2013/05/14
Committee: ENVI

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

~~(b) to contribute to the scrutiny of certain conformity assessments pursuant to Article 44;~~deleted

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 requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies;.

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;~~deleted

2013/05/14
Committee: ENVI

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

~~(f) to contribute to harmonised administrative practice with regard to medical devices in the Member States.~~deleted

2013/05/14
Committee: ENVI

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

(f a) (d) to continuously monitor the technical progress in particular in the field of implantable devices and assess whether the essential requirements on safety and performance provided within this Regulation are appropriate to ensure safety and performance of medical devices and identify the need to amend Annex I; (fb) to develop guidelines on clinical trials of certain medical devices (fc) to contribute to the development of medical devices standards; (fd) to contribute to the development of Common Technical Specifications (CTS) (fe) to develop and maintain a framework for a European market surveillance program; (ff) to develop minimum requirements on a quality management system for national market surveillance authorities . (fg) to organise joint market surveillance and joint testing projects; (fh) to organise training programmes and exchanges of national officials on market surveillance, on notified bodies designation and monitoring and on clinical investigations; (fi) to organise information campaigns and joint visit programmes; (fj) to provide an opinion on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices according to Article 41 paragraph 3 within six months (fk) to provide at the Commission's request an opinion on a the classification of a device, or category or group of devices according to Article 41 paragraph 4.

2013/05/14
Committee: ENVI

Proposal for a regulation
Article 94 – paragraph 4

4. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation before its date of application if it has been ensured that the relevant delegated legal acts and implementing acts have been implemented.

2013/05/14
Committee: ENVI

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~~

2013/05/14
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 II – point 11 – point 11.7

11.7. Devices shall be designed and manufactured in such a way as to facilitate the safe disposal of the device, of substances with which it has been treated and/or of any waste substances by the user, patient or other person and, where possible and appropriate, the device shall be replaced with a device with a higher safety standard. This should particularly be intended to reduce dangers to patients and users which may arise from exposure to chemical or nuclear material.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 1 – part II – point 13 – point 13.1 – point a

(a) Devices shall be designed and manufactured and packaged in such a way that exposure of patients, users and other persons to any emitted radiation shall be reduced as far as possible and appropriate, compatible with the intended purpose, and if possible these applications shall be replaced with applications with a higher safety standard, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 1 – part II – point 13 – point 13.3 – paragraph 1

Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible and appropriate: where possible, methods should be selected which reduce the exposure to radiation of patients, users and other persons who may be affected.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 1 – part II – point 13 – point 13.4 – point a

(a) Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that, where possible, the quantity, geometry and energy distribution (or quality) of radiation emitted can be varied and controlled taking into account the intended use, and if possible, devices should be used that can at any time during and after treatment monitor the emission of radiation.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 1 – part II – point 16 – introductory part

16. Protection against ~~mechanical and thermal risks~~risks arising from devices which are intended by manufacturers for self-testing

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 2 – paragraph 1 – point 5 – paragraph 1 – introductory part

The documentation shall contain a ~~summary of~~ll available information concerning:

2013/05/14
Committee: ENVI

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

1. The CE marking shall consist of the initials ‘“CE” with the addition of the words ‘medical device’ taking the following form:

2013/05/14
Committee: ENVI

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

– are active and 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 cClass III,

2013/05/14
Committee: ENVI

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

~~– are intended specifically to control, diagnose, monitor or correct a de~~Does not affect 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,~~English version.

2013/05/14
Committee: ENVI

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 and implantable devices intended specifically for use for monitoring or diagnosis or to detect or correct faults in the central nervous system, involving direct contact with these parts of the body, in which case they are in class III,

2013/05/14
Committee: ENVI

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,

2013/05/14
Committee: ENVI

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

~~– are intended specifically to control, diagnose, monitor or correct a de~~Does not affect 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,~~English version.

2013/05/14
Committee: ENVI

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,

2013/05/14
Committee: ENVI

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.

2013/05/14
Committee: ENVI

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 purposewhose mode of functioning entails the deliberate release of nanomaterial into the human body are in class III.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 7 – part III – point 6 – point 6.8 – paragraph 1

~~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 13 – point 2

2. Confirmation of conformity with the requirements concerning the characteristics and performances referred to in Section 1 of Annex I, under the normal conditions of use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit/risk ratio referred to in Sections 1 and 5 of Annex I, shall be based on clinical data. Data from independent scientific institutions or medical societies based on their own collections of clinical data shall also be taken into account.

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. DIn the case of novel devices, 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 14 – part I – point 1 – paragraph 1

Every step in the clinical investigation, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th World Medical ~~Association General~~ Assembly in Helsinki, Finland, in 1964, and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008. Regulation of the detailed requirements relating to the participation of subjects in clinical trials shall be the responsibility of the Member States.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 14 – part II – point 3 – point 3.1 – point 3.1.3

3.1.3. Information on the principal investigator, coordinating investigator, including their qualifications, and on the investigation site(s), as well as information about the contract between the sponsor and the investigating establishment, together with details of the funding.

2013/05/14
Committee: ENVI

Proposal for a regulation
Annex 14 – part II – point 3 – point 3.1 – point 3.1.4

3.1.4. Overall synopsis of the clinical investigation in the national language of the country concerned.

2013/05/14
Committee: ENVI