Activities of Zofija MAZEJ KUKOVIČ related to 2012/0266(COD)
Plenary speeches (1)
In vitro diagnostic medical devices - Medical devices (debate)
Amendments (38)
Amendment 160 #
Proposal for a regulation
Recital 13
Recital 13
(13) There is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices. In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial, with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of medical devices, the manufacturers should take special care when using nanoparticles that can be released to the human body and those devices should be subject to the most severe conformity assessment procedure and the same standards.
Amendment 164 #
Proposal for a regulation
Recital 24
Recital 24
(24) It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors as laid down in the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the different parts of this Regulation, to enhance understanding of the legal requirements and thus to improve regulatory compliance by the relevant operators. Conditions enabling small and medium-sized enterprises with smart specialisation to have easier access to this market should be established.
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 184 #
Proposal for a regulation
Recital 39
Recital 39
(39) For high-risk medical devices, in the interests of increased transparency, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.
Amendment 193 #
Proposal for a regulation
Recital 44
Recital 44
(44) The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products. For medical devices in classes IIa, IIb and III, an appropriate level of involvement of a notified body shouldall be compulsory, with medical devices in class III requiring explicit prior approval of their design and manufacture before they can be placed on the market.
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 206 #
Proposal for a regulation
Recital 54
Recital 54
(54) The assessment of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State coordination, with the objective of sharing resources and ensuring consistency regarding the corrective action, and transparency of procedures should be ensured.
Amendment 213 #
Proposal for a regulation
Recital 61
Recital 61
(61) The Commission should provide scientific, technical and corresponding logistic support to the coordinating national authority and ensure that the regulatory system for medical devices is effectively and uniformly implemented at Union level based on sound scientific evidence.
Amendment 214 #
Proposal for a regulation
Recital 63
Recital 63
(63) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the principle of free and informed consent, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property, as well as the Convention on Human Rights. This Regulation should be applied by the Member States in accordance with those rights and principles.
Amendment 221 #
Proposal for a regulation
Recital 68
Recital 68
(68) To allow economic operators, notified bodies, Member States and the Commissionespecially SMEs, to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements to be taken for its proper application. However, parts of the Regulation that affect directly Member Sates and the Commission should be implemented as soon as possible. It is particularly important that by the date of application, a sufficient number of notified bodies are designated in accordance with the new requirements to avoid any shortage of medical devices on the market. Also at the date of application, existing notified bodies that handle class III devices, shall be subject to an application for notification in accordance with Article 31.
Amendment 230 #
Proposal for a regulation
Article 1 – paragraph 7 a (new)
Article 1 – paragraph 7 a (new)
7a. The regulation of medical devices at Union level shall not interfere with the freedom of Member States to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.
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 285 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. A device offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC to a natural or legal person established in the Union shall comply with this Regulation at the latest whenby the day on which the device is placed on the market.
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 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 484 #
Proposal for a regulation
Article 28 – paragraph 7
Article 28 – paragraph 7
7. Member States shall provide the Commission and the other Member States with information on their procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto. Such information shall be publicly available
Amendment 507 #
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. The full details of the notification, including annexes, shall be made publicly available.
Amendment 517 #
Proposal for a regulation
Article 35 – paragraph 4
Article 35 – paragraph 4
4. Three years after notification of a notified body, and again every third year thereafter, the assessment to determine whether the notified body and its subsidiaries and sub contractors 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. The full results of the assessments shall be published.
Amendment 522 #
Proposal for a regulation
Article 36 – paragraph 3
Article 36 – paragraph 3
3. In the event of restriction, suspension or withdrawal of a notification, the Member State shall immediately inform the Commission which shall take appropriate steps to ensure that the files of the notified body concerned are either processed by another notified body or kept available for the national authorities responsible for notified bodies and for market surveillance at their request.
Amendment 634 #
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1 – point a
Article 61 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident in respect of devices made available on the Union market;
Amendment 638 #
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 and facilitate healthcare professionals, 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 641 #
Proposal for a regulation
Article 61 – paragraph 4
Article 61 – paragraph 4
4. Manufacturers of custom-made devices shall immediately report any serious incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the Member State in which the device in question has been made available.
Amendment 652 #
Proposal for a regulation
Article 63 – paragraph 1 – subparagraph 1
Article 63 – paragraph 1 – subparagraph 1
Member States shall take the necessary steps to ensure that any information regarding a seriousn incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 61 is, at national level, evaluated centrally by their competent authority, if possible together with the manufacturer.
Amendment 655 #
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
2. The national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions, taking into account criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of harm and severity of harm, clinical benefit of the device, intended and potential users, and population affected. They shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action. They shall monitor the manufacturer's investigation of the incident.
Amendment 656 #
Proposal for a regulation
Article 63 – paragraph 3 – subparagraph 1
Article 63 – paragraph 3 – subparagraph 1
In the case of devices referred to in the first subparagraph of Article 1(4) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for medicinal products, or the European Medicines Agency (EMA), that was consulted by the notified body in accordance with the second subparagraph of Article 42(2).
Amendment 657 #
Proposal for a regulation
Article 63 – paragraph 3 – subparagraph 2
Article 63 – paragraph 3 – subparagraph 2
In the case of devices covered by this Regulation in accordance with point (e) of Article 1(2) and where the serious incident or field safety corrective action may be related to the tissues or cells of human origin utilised for the manufacture of the device, the competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for human tissues and cells that was consulted by the notified body in accordance with the third subparagraph of Article 42(2).
Amendment 659 #
Proposal for a regulation
Article 63 – paragraph 6 – subparagraph 1 – point a
Article 63 – paragraph 6 – subparagraph 1 – point a
(a) where similar serious incidents related to the same device or type of device of the same manufacturer occur in more than one Member State;
Amendment 660 #
Proposal for a regulation
Article 63 – paragraph 7 – subparagraph 1 – point a
Article 63 – paragraph 7 – subparagraph 1 – point a
(a) to monitor the investigation of the serious incident by the manufacturer and the corrective action to be taken;
Amendment 661 #
Proposal for a regulation
Article 63 – paragraph 7 – subparagraph 1 – point b
Article 63 – paragraph 7 – subparagraph 1 – point b
(b) to consult with the notified body that issued a certificate in accordance with Article 45 for the device in question regarding the impact of the serious incident on the certificate;
Amendment 662 #
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
Manufacturers of devices classified in class IIb and III shall report to the electronic system referred to in Article 62 any statistically significant increase in the frequency or severity of incidents that are not seriousall incidents or of expected undesirable side-effects that have a significant impact on the risk-benefit analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons when weighted against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable side-effects in respect of the device, or category or group of devices, in question during a specific time period as established in the manufacturer's conformity assessment. Article 63 shall apply.
Amendment 664 #
Proposal for a regulation
Article 66 – paragraph 1 – point a
Article 66 – paragraph 1 – point a
(a) typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices;
Amendment 665 #
Proposal for a regulation
Article 66 – paragraph 1 – point b
Article 66 – paragraph 1 – point b
(b) harmonised forms for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers as referred to in Articles 61 and 64;
Amendment 666 #
Proposal for a regulation
Article 66 – paragraph 1 – point c
Article 66 – paragraph 1 – point c
(c) timelines for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers, taking into account the severity of the event to be reported as referred to in Articles 61 and 64;
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 687 #
Proposal for a regulation
Article 70 – paragraph 3 – point 1 (new)
Article 70 – paragraph 3 – point 1 (new)
(1) Where the concerned devices are to be recalled, the economic operator shall make all reasonable efforts to complete the recall before the end of clearly defined period communicated to it by the competent authority as referred to in paragraph 1,
Amendment 809 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – introductory part
Annex 6 – point 3 – point 3.1 – point 3.1.1 – introductory part
3.1.1. A notified body shall be capable of carrying out all the tasks assigned to it by this Regulation with the highest degree of professional integrity and the requisite technical competence in the specific field, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility. The process shall be monitored to ensure that it is of the requisite quality.
Amendment 820 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.3 – indent 5
Annex 6 – point 3 – point 3.2 – point 3.2.3 – indent 5
– the types of qualifications (knowledge, experience and other competence) required for carrying out standards-based conformity assessments in relation to medical devices as well as the relevant qualification criteria;
Amendment 837 #
Proposal for a regulation
Annex 6 – point 4 – point 4.1
Annex 6 – point 4 – point 4.1
4.1. The notified body's decision-making process must be transparent and shall be clearly documented, including the process for the issue, suspension, reinstatement, withdrawal or refusal of conformity assessment certificates, their modification or restriction and the issue of supplements.