44 Amendments of Peter LIESE related to 2012/0266(COD)
Amendment 148 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) In the area of medical devices many SMEs are active. This should be taken in account when regulating the sector without compromising the safety and health aspects.
Amendment 176 #
Proposal for a regulation
Recital 33
Recital 33
(33) Medical devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose. Member States should not create obstacles to their placing on the market or putting into service for reasons related to the requirements laid down in this Regulation. However Member States should be allowed to decide whether to restrict the use of any specific type of medical device in relation to aspects that are not covered by this Regulation.
Amendment 179 #
Proposal for a regulation
Recital 34
Recital 34
(34) The traceability of medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock-management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.
Amendment 199 #
Proposal for a regulation
Recital 48 a (new)
Recital 48 a (new)
Amendment 202 #
Proposal for a regulation
Recital 51 a (new)
Recital 51 a (new)
(51a) Clinical investigations involving risk for the subject should only be allowed after assessment and approval by an ethics committee.
Amendment 203 #
Proposal for a regulation
Recital 51 b (new)
Recital 51 b (new)
(51b) Strict rules for persons unable to give informed consent such as children and incapacitated persons should be established at the same level as in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use¹. ¹ OJ L 121, 1.5.2001, p. 34.
Amendment 219 #
Proposal for a regulation
Recital 64
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.
Amendment 231 #
Proposal for a regulation
Article 1 – paragraph 8 a (new)
Article 1 – paragraph 8 a (new)
8a. This regulation does not interfere with the decision made by Member States whether to restrict the use of any specific type of medical device for aspects that are not harmonised by this regulation
Amendment 233 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 1
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 1
– diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease,
Amendment 262 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 33
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;
Amendment 264 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 37
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;
Amendment 266 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 37 a (new)
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.
Amendment 268 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 39 – indent 3
Article 2 – paragraph 1 – subparagraph 1 – point 39 – indent 3
– foetal distress, foetal death or a congenital abnormalityphysical or mental impairments or birth defect;
Amendment 284 #
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 298 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
Amendment 303 #
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 1
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.
Amendment 349 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point a
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;
Amendment 354 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point b
Article 13 – paragraph 1 – subparagraph 1 – point b
(b) fivetwo years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Amendment 430 #
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
Amendment 447 #
Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)
Article 24 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices
Amendment 458 #
Proposal for a regulation
Article 26 – paragraph 1
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 summaryreport 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.
Amendment 551 #
Proposal for a regulation
Article 42 – paragraph 11
Article 42 – paragraph 11
Amendment 608 #
Proposal for a regulation
Article 50 – paragraph 1 – point a
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;
Amendment 609 #
Proposal for a regulation
Article 50 – paragraph 1 – point b
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;
Amendment 610 #
Proposal for a regulation
Article 50 – paragraph 3
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.
Amendment 611 #
Proposal for a regulation
Article 51 – paragraph 2 – subparagraph 1
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 six14 days after receipt of the application, the Member State concerned shall notify the sponsor whether the clinical investigationperformance study falls within the scope of this Regulation and whether the application is complete.
Amendment 612 #
Proposal for a regulation
Article 51 – paragraph 2 – subparagraph 1 a (new)
Article 51 – paragraph 2 – subparagraph 1 a (new)
In case of more than one Member State concerned, where there is a disagreement on whether the clinical investigation should be approved, the member states concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the European Commission takes a decision after hearing the member states concerned.
Amendment 613 #
Proposal for a regulation
Article 51 – paragraph 3 – subparagraph 3
Article 51 – paragraph 3 – subparagraph 3
Where the Member State has not notified the sponsor according to paragraph 2 within threesix 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.
Amendment 614 #
Proposal for a regulation
Article 51 – paragraph 5 a (new)
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.
Amendment 616 #
Proposal for a regulation
Article 51 – paragraph 5 – point b
Article 51 – paragraph 5 – point b
Amendment 617 #
Proposal for a regulation
Article 51 – paragraph 5 – point c
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.
Amendment 618 #
Proposal for a regulation
Article 51 a (new)
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.
Amendment 637 #
Proposal for a regulation
Article 61 – paragraph 3 – subparagraph 1
Article 61 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 739 #
Proposal for a regulation
Article 81 – paragraph 2 – point b
Article 81 – paragraph 2 – point b
(b) to provide scientific advice regardingand technical assistance regarding the definition of the state of the art in relation to specific devices, or a category or group of devices;
Amendment 740 #
Proposal for a regulation
Article 81 – paragraph 2 – point f
Article 81 – paragraph 2 – point f
(f) to contribute to the development of standards atcommon technical specifications (CTS) as well as of international level;standards
Amendment 778 #
Proposal for a regulation
Annex 1 – part II – point 9 – point 9.2
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 intended to be absorbed by or dispersed in the human body in order to achieve the desired effect shall comply, by analogy, with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
Amendment 784 #
Proposal for a regulation
Annex 1 – part II – point 13 – point 13.3 – paragraph 1
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.
Amendment 870 #
Proposal for a regulation
Annex 8 – point 4 – point 4.4 – introductory part
Annex 8 – point 4 – point 4.4 – introductory part
4.4. The notified body shall randomly perform unannounced factory inspections to the manufacturer 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. The notified body shall carry out such inspections at least once every three years.
Amendment 898 #
Proposal for a regulation
Annex 14 – part I – point 1 – paragraph 1
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.
Amendment 899 #
Proposal for a regulation
Annex 14 – part I – point 1 a (new)
Annex 14 – part I – point 1 a (new)
Amendment 900 #
Proposal for a regulation
Annex 14 – part I – point 1 – paragraph 1 a (new)
Annex 14 – part I – point 1 – paragraph 1 a (new)
1b. Clinical investigation on minors A Clinical investigation on minors may be conducted only where, in addition to the general conditions, all of the following conditions are met: – the informed consent of the legal representative has been obtained, whereby consent shall represent the minor's presumed will; – the minor has received all relevant information in a way adapted to the minor's age and maturity, from a medical doctor (either the investigator or member of the study team) trained or experienced in working with children, regarding the investigation, the risks and the benefits; – the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to above to refuse participation in, or to be withdrawn from, the clinical investigation at any time, is duly taken into consideration by the investigator; – no incentives or financial inducements are given other than compensation for participation in the clinical investigation – such research is essential to validate data obtained in clinical investigation on persons able to give informed consent or by other research methods; – such research either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors; – the clinical investigation has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage, and both the risk threshold and the degree of distress are specially defined and constantly observed; – some direct benefit for the group of patients is obtained from the clinical investigation – the corresponding scientific guidelines of the Agency have been followed; – an ethics committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol. The minor shall take part in the consent procedure in a manner adapted to his or her age and maturity.
Amendment 901 #
Proposal for a regulation
Annex 14 – part II – point 3 – point 3.1 – point 3.1.3
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.
Amendment 902 #
Proposal for a regulation
Annex 14 – part II – point 3 – point 3.1 – point 3.1.4
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.
Amendment 903 #
Proposal for a regulation
Annex 14 – part II – point 3 – point 3.15 a (new)
Annex 14 – part II – point 3 – point 3.15 a (new)
3.15 a. A plan for the further treatment of subjects after the clinical investigation.