47 Amendments of Anna ROSBACH related to 2012/0266(COD)
Amendment 166 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) To ensure that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by medical devices, manufacturers shall be obliged to take liability insurance with appropriate coverage.
Amendment 174 #
Proposal for a regulation
Recital 32
Recital 32
(32) Patients who are implanted with a device should be given where possible in advance essential information related to the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls.
Amendment 181 #
Proposal for a regulation
Recital 35
Recital 35
(35) Transparency and better information that is understandable, reliable, objective, easily accessible and non-promotional are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Amendment 189 #
Proposal for a regulation
Recital 42
Recital 42
(42) For high risk medical devices, competent authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right, on scientifically valid grounds, to scrutinise the preliminary assessment conducted by notified bodies, in particular regarding novel devices, devices for which a novel technology is being used, devices belonging to a category of devices with increased serious incident rates, or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices. The process foreseen in this Regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk medical device before submitting the application to the notified body.
Amendment 197 #
Proposal for a regulation
Recital 47
Recital 47
(47) The rules on clinical investigations should be in line with major international guidance in this field, such as the international standard ISO 14155:2011 or any subsequent version of it on good clinical practice for clinical investigations of medical devices for human subjects and the most recent (2008) version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects to ensure that clinical investigations conducted in the Union are accepted elsewhere and that clinical investigations conducted outside the Union in accordance with international guidelines can be accepted under this Regulation.
Amendment 198 #
Proposal for a regulation
Recital 48
Recital 48
(48) An electronic system should be set up at Union level to ensure that every clinical investigation is registered in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union, no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations on medical devices should be interoperable with the EU database, as well as the www.clinicaltrials.gov database of the USA FDA to be set up for clinical trials on medicinal products for human use.
Amendment 201 #
Proposal for a regulation
Recital 50
Recital 50
(50) Sponsors should report certain adverse events, including Serious adverse Device Effects, device effects and device deficiencies occurring during clinical investigations to the Member States concerned, which should have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation. Such information should be communicated to the other Member States.
Amendment 227 #
Proposal for a regulation
Article 1 – paragraph 2 – point f a (new)
Article 1 – paragraph 2 – point f a (new)
(fa) To devices that are composed of substances or combination of substances intended to be ingested and that are absorbed by or dispersed in the human body that based on robust scientific evidence pose no adverse health implications to patient safety.
Amendment 240 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 2
Article 2 – paragraph 1 – subparagraph 1 – point 2
(2) ‘'accessory to a medical device’' means an article which, whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s) or to specifically assist the medical functionality of the device(s) in view of its/their intended purpose(s);
Amendment 258 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 24
Article 2 – paragraph 1 – subparagraph 1 – point 24
(24) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health;
Amendment 259 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 27 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 27 – introductory part
(27) ‘reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoration of the technical and functional safety of the used device; routine device maintenance service activities are not included in this definition;
Amendment 267 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 39 – indent 2 – point iii
Article 2 – paragraph 1 – subparagraph 1 – point 39 – indent 2 – point iii
(iii) hospitalisation or extending the duration ofprolongation of patient hospitalisation,
Amendment 275 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, at the request of a Member State, or after consultation wits own initiativeh the Member States, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 279 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Commission shall ensure the sharing of expertise between Member States and relevant stakeholders including patient groups in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products in order to determine the appropriate regulatory status of a product, or category or group of products.
Amendment 282 #
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23 to, 26 and 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the health institution's single quality management system.
Amendment 288 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post- market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3).
Amendment 306 #
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 2
Article 8 – paragraph 6 – subparagraph 2
If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures, including the immediate reporting to the European databank on medical devices (Eudamed)set up by the Commission Decision 2010/227/EU.
Amendment 310 #
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall, in response to a reasoned request from a competent authority, or from a legitimate health institution or association, 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.
Amendment 317 #
Proposal for a regulation
Article 8 – paragraph 10 a (new)
Article 8 – paragraph 10 a (new)
Amendment 347 #
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 at university level, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least twofive years of professional experience in regulatory affairs or in quality management systems relating to medical devices;
Amendment 352 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point b
Article 13 – paragraph 1 – subparagraph 1 – point b
(b) fiveten years of professional experience in regulatory affairs or in quality management systems relating to medical devices as well as a proven in-depth knowledge of both the therapeutic area and the product type(s) concerned.
Amendment 364 #
Proposal for a regulation
Article 13 – paragraph 2 – point c
Article 13 – paragraph 2 – point c
(c) that the reporting obligations in accordance with Articles 59 and 61 to 66 are fulfilled;
Amendment 367 #
Proposal for a regulation
Article 13 – paragraph 2 – point d
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 and the obligations on Serious Adverse Events reporting are fulfilled.
Amendment 372 #
Proposal for a regulation
Article 13 – paragraph 4 – point a
Article 13 – paragraph 4 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least twofive years of professional experience in regulatory affairs or in quality management systems relating to medical devices;
Amendment 374 #
Proposal for a regulation
Article 13 – paragraph 4 – point b
Article 13 – paragraph 4 – point b
(b) fiveten years of professional experience in regulatory affairs or in quality management systems relating to medical devices as well as a proven in-depth knowledge of both the therapeutic area and the product(s) concerned.
Amendment 376 #
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1 – point c
Article 14 – paragraph 1 – subparagraph 1 – point c
(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected; this includes the reuse of a device outside of the specifications set out in the manufacturer's instructions for use.
Amendment 385 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person, including health institutions as specified at Art. 4.4, 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.
Amendment 388 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Only single-use devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed, and only if this allowed under national legislation as well as can be proved by the reprocessor to be safe for the patient.
Amendment 394 #
Proposal for a regulation
Article 15 – paragraph 3 a (new)
Article 15 – paragraph 3 a (new)
3a. In case of reprocessing of single-use medical devices the legal or natural person referred to in paragraph 1 shall ensure the traceability of each reprocessed device, including clear indications for how many times the device has already been reprocessed.
Amendment 395 #
Proposal for a regulation
Article 15 – paragraph 3 b (new)
Article 15 – paragraph 3 b (new)
3b. The legal or natural person referred to in paragraph 1 shall establish a maximum number of times a single-use device can be reprocessed and shall ensure that the device is not reprocessed more times than this level.
Amendment 401 #
Proposal for a regulation
Article 15 – paragraph 6 a (new)
Article 15 – paragraph 6 a (new)
6a. Patients shall always be informed when reprocessed single-use devices are used.
Amendment 459 #
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 summaryprovide a report of safety and clinical performance, including full results of clinical studies and trials. It shall be written in a way that is clear to the intended user, differentiating between the information needs of patients and healthcare professionals. 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. The summary shall also be made public.
Amendment 468 #
Proposal for a regulation
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
(a) to enable the public to be adequately informed via a central information point where patients can ask, seek and find information about devices placed on the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators; The Commission should develop guidelines in consultation with stakeholders, including Member State competent authorities, the research community and patient and consumer organisations, and to specify the exact content and format of the information that should be published.
Amendment 477 #
Proposal for a regulation
Article 27 – paragraph 4
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, healthcare professionals, sponsors and the public to the extent defined in the provisions referred to in paragraph 2.
Amendment 481 #
Proposal for a regulation
Article 28 – paragraph 1 – point 1 (new)
Article 28 – paragraph 1 – point 1 (new)
(1) Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 492 #
Proposal for a regulation
Article 31 – paragraph 2 – subparagraph 1
Article 31 – paragraph 2 – subparagraph 1
The application shall specifybe accompanied by a description of the conformity assessment activities, the conformity assessment procedures and the devices for which the body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Annex VI or supported by documentation proving compliance with all the requirements set out in Annex VI.
Amendment 506 #
Proposal for a regulation
Article 33 – paragraph 9
Article 33 – paragraph 9
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly. Details of the notification, such as the class and the typology of devices shall be made publicly available.
Amendment 527 #
Proposal for a regulation
Article 37 – paragraph 3 – subparagraph 1
Article 37 – paragraph 3 – subparagraph 1
Where the Commission ascertains that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification if necessary. A report with the opinions of Member States should be made publicly available by the European Commission after the assessment.
Amendment 533 #
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. The Member State where the bodies are established shall levy fees on 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 fees shall be transparent and proportionate in nature and be subject to member state labour markets.
Amendment 562 #
Proposal for a regulation
Article 44
Article 44
Amendment 563 #
Proposal for a regulation
Article 44
Article 44
Amendment 623 #
Proposal for a regulation
Article 53 – paragraph 1 – point b
Article 53 – paragraph 1 – point b
(b) the exchange of information between the Member States and between them and the Commission in accordance with Article 56; All relevant updates to the information concerning an investigation should be posted on the database, such as measures taken by Member States to terminate, suspend or modify an investigation, as well as updated information on the benefit-risk balance or any urgent safety measures taken.
Amendment 631 #
Proposal for a regulation
Article 59 – paragraph 1 – point d
Article 59 – paragraph 1 – point d
(d) new findings in relation to any event referred to in points (a) to (c). Information regarding incidents that are caused by user errors should also be collected, as they are a major source of incidents with medical devices. This information can contribute to improve the safety and knowledge of the device. The Regulation should also provide for Member States to put in place non- electronic formats of reporting to ensure that patients who do not have online access are able to report.
Amendment 675 #
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. The Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every fourtwo years and the results thereof shall be communicated to the other Member States and the Commission. The Member State concerned shall make a summary of the results accessible to the public.
Amendment 717 #
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
Amendment 895 #
Proposal for a regulation
Annex 13 – point 5 a (new)
Annex 13 – point 5 a (new)
5 a. All clinical data collected by the manufacturer as part of a PMCF should be made accessible to health professionals.
Amendment 897 #
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 2008any subsequent amendments.