27 Amendments of Peter LIESE related to 2012/0267(COD)
Amendment 86 #
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic 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 in vitro diagnostic 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 111 #
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
Amendment 115 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4
Article 2 – paragraph 1 – subparagraph 1 – point 4
(4) ‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including testing services offered to lay persons by means of information society services;
Amendment 116 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 6
Article 2 – paragraph 1 – subparagraph 1 – point 6
(6) ‘companion diagnostic’ means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targetedspecific therapy;
Amendment 120 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development.
Amendment 132 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 48
Article 2 – paragraph 1 – subparagraph 5 – point 48
(48) ‘device deficiency’ means any inadequacy in the identity, quality, durstability, reliability, safety or performance of a device for performance evaluation, including malfunction, use errors or inadequacy in the information supplied by the manufacturer;
Amendment 140 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2
Article 4 – paragraph 5 – subparagraph 2
Devices classified as class D in accordance with the rules set out in Annex VII, even if manufactured and used within a single health institution, shall comply withbe exempt from the requirements of this Regulation. However, the provis, with the exception of Article 59(4) and general safety performance requirements set out in Annex 1 where the following conditions aregarding met: (a) the recipient patient or patient group’s specific needs can not be met by an available CE -marking set out in Article 16 and the obligationsed device; (b) the health institution is accredited to ISO standard 15189 quality management system, or any other equivalent recognised standard; (c) the health institution provides the competent authority referred to in Articles 21 to 25 shall not apply to those devices. 6 with a list of such devices, which shall include a justification of their manufacturing, modification or use, in particular, where similar devices have been made available on the market. This information shall be made public. Member States shall retain the right to restrict the in-house manufacture and use of any specific type of in-vitro diagnostic device in relation to aspects that are not covered by this Regulation, and may also make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 143 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 144 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 174 #
Proposal for a regulation
Article 12 – paragraph 4
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 that, within the limits of its respective activities, 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.
Amendment 177 #
Proposal for a regulation
Article 13 – paragraph 1 – point a
Article 13 – paragraph 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 in vitro diagnostic medical devices;
Amendment 179 #
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) fivetwo years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
Amendment 182 #
Proposal for a regulation
Article 14 – paragraph 4 a (new)
Article 14 – paragraph 4 a (new)
4a. Distributors or affiliates who carry out – on behalf of the manufacturer – one or several of the activities mentioned under paragraph 2 points (a) and (b) – are exempted from additional requirements under points (3) and (4).
Amendment 189 #
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
Amendment 259 #
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 2
Article 40 – paragraph 2 – subparagraph 2
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safeas specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and sperformance that is at least equivalent, as specified in Section 5.4 of Annex VIII ancificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established in Sfection 3.5 of Annex IX.
Amendment 282 #
Proposal for a regulation
Article 49 – paragraph 2 – subparagraph 1 a (new)
Article 49 – paragraph 2 – subparagraph 1 a (new)
In case of more than one Member State concerned, where there is a disagreement on whether the clinical performance study 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, and if appropriate taking advice from EMA.
Amendment 309 #
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – 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 331 #
Proposal for a regulation
Article 78 – paragraph 2 – point b
Article 78 – paragraph 2 – point b
(b) to carry out appropriate laboratory tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 5.7 of Annex VIII and in Section 5.1 of Annex X;
Amendment 333 #
Proposal for a regulation
Article 78 – paragraph 2 – point d
Article 78 – paragraph 2 – point d
(d) 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 334 #
Proposal for a regulation
Article 78 – paragraph 2 – point f
Article 78 – paragraph 2 – point f
(f) to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and, in particular for batch verification of class D devices and for market surveillance;
Amendment 335 #
Proposal for a regulation
Article 78 – paragraph 2 – point i
Article 78 – paragraph 2 – point i
(i) to contribute to the development of standards atcommon technical specifications (CTS) as well as of international level;standards
Amendment 336 #
Proposal for a regulation
Article 78 – paragraph 3 – point a
Article 78 – paragraph 3 – point a
(a) to have appropriately qualified staff with adequate knowledge and experience in the field of the in vitro diagnostic medical devices for which they are designated; appropriate knowledge and experience shall be based on - experience of assessing high-risk IVDs and of carrying out the relevant laboratory tests; - in-depth knowledge of high-risk in-vitro diagnostic medical devices and relevant technologies; - proven laboratory experience in one of the following areas: testing or calibration laboratory, supervisory authority or institution, national reference laboratory for class D devices, quality control of in- vitro diagnostic medical devices, development of reference materials for IVDs, calibration of diagnostic medical devices; laboratories or blood banks which experimentally assess and use high-risk IVDs or, where applicable, manufacture them in-house; - knowledge and experience of product or batch testing, quality checks, design, manufacture and use of IVDs; - knowledge of the health risks faced by patients, their partners and recipients of blood/organ/tissue donations/preparations associated with the use and, in particular, malfunctioning of high-risk IVDs; - knowledge of this Regulation and of applicable laws, rules and guidelines, knowledge of the Common Technical Specifications (CTS), applicable harmonized standards, product-specific requirements and relevant guidance documents; - participation in relevant external and internal quality assessment schemes organised by international or national organisations.
Amendment 337 #
Proposal for a regulation
Article 78 – paragraph 5
Article 78 – paragraph 5
5. Where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, they mayshall be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to a set of predetermined and transparent terms and conditions.
Amendment 358 #
Proposal for a regulation
Annex 3 – point 7
Annex 3 – point 7
Amendment 390 #
Proposal for a regulation
Annex 8 – section 2 – point 5 – point 5.7
Annex 8 – section 2 – point 5 – point 5.7
5.7. To verify conformity of manufactured devices classified as class D, the manufacturer shall carry out tests on the manufactured devices or each batch of devices. After the conclusion of the controls and tests he shall forward to the notified body without delay the relevant reports on these tests. Furthermore, the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre-agreed conditions and modalities which shall include that the notified body or the manufacturer, in regular intervals, shall send samples of the manufactured devices or batches of devices to a reference laboratory, where designated in accordance with Article 78, to carry out appropriate tests. The reference laboratory shall inform the notified body about its findings.
Amendment 393 #
Proposal for a regulation
Annex 8 – section 2 – point 6 – point 6.2 – point e
Annex 8 – section 2 – point 6 – point 6.2 – point e
(e) The notified body shall give due consideration to the opinion, if any, expressed by the medicinal products competent authority concerned or the EMA when making its decision. It shall convey its finalon the scientific suitability of the companion diagnostic when making its decision. If the notified body deviates from that position, it shall justify its decision to the medicinal products competent authority concerned or to the EMA. If no agreement is reached, the notified body shall inform the MDCG thereof. The design- examination certificate shall be delivered in accordance with point (d) of Section 6.1.
Amendment 397 #
Proposal for a regulation
Annex 10 – point 5 – point 5.1
Annex 10 – point 5 – point 5.1
5.1. In the case of devices classified as class D, the manufacturer shall carry out tests on the manufactured devices or each batch of devices. After the conclusion of the controls and tests he shall forward to the notified body without delay the relevant reports on these tests. Furthermore, the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre-agreed conditions and modalities which shall include that the notified body or the manufacturer, in regular intervals, shall send samples of the manufactured devices or batches of devices to a reference laboratory, where designated in accordance with Article 78, to carry out appropriate laboratory tests. The reference laboratory shall inform the notified body about its findings