29 Amendments of Anna ROSBACH 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 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 121 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 3 – point 21
Article 2 – paragraph 1 – subparagraph 3 – point 21
(21) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health;
Amendment 131 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 47 – indent 2 – point iii
Article 2 – paragraph 1 – subparagraph 5 – point 47 – indent 2 – point iii
(iii) hospitalisation or extending the duration ofprolongation of patient hospitalisation,
Amendment 144 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 148 #
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,For Class D devices and as needed for companion diagnostics, where no harmonised standards exist or where there is a need to address a public health concern 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 evidence and post-market follow-up set out in Annex XII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 84(3).
Amendment 149 #
Proposal for a regulation
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3a. The relevant scientific experts from the various interested parties shall be involved in the drafting of the common technical specifications.
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 176 #
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 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 in vitro diagnostic medical devices;
Amendment 178 #
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) five10 years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices as well as a proven in- depth knowledge of both the therapeutic area and the product type(s) concerned.
Amendment 180 #
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 in vitro diagnostic medical devices;
Amendment 181 #
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 in vitro diagnostic medical devices as well as a proven in- depth knowledge of both the therapeutic area and the product(s) concerned..
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 195 #
Proposal for a regulation
Article 26 – paragraph 1 – subparagraph 2 (new)
Article 26 – paragraph 1 – subparagraph 2 (new)
Member States may decide that the assessment and monitoring referred to in the first subparagraph shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 208 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 1
Article 29 – 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 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 260 #
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 3
Article 40 – paragraph 2 – subparagraph 3
For companion diagnostics intended to be used to assess the patient eligibility for treatment with a specific medicinal product, the notified body shall consult one of the competent authwhere a reference laboratory has been designated in accordance with Article 78, the notified body performing the conformities designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human usy assessment shall request that reference laboratory to verify compliance orf the European Medicines Agency (EMA) in accordance with the procedures set out in Section 6.2 of Annex VIII and in Section 3.6 of Annex IXdevice with the applicable CTS, when available.
Amendment 262 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 3
Article 40 – paragraph 3 – subparagraph 3
For companion diagnostic intended to be used to assess the patient eligibility to a treatment with a specific medicinal product, the notified body shall consult one of the competent authwhere a reference laboratory is designated in accordance with Article 78, the notified body performing the conformities designated by the Member States in accordance with Directive 2001/83/EC or the European Medicines Agency (EMA) in accordy assessment shall request that reference laboratory to verify compliance withof the procedures set out in Section 6.2 of Annex VIII and in Section 3.6 of Annex IXdevice with the applicable CTS, when available.
Amendment 272 #
Proposal for a regulation
Article 42
Article 42
deleted
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 322 #
Proposal for a regulation
Article 77 – paragraph 1 – point b
Article 77 – paragraph 1 – point b
Amendment 332 #
Proposal for a regulation
Article 78 – paragraph 2 – point b
Article 78 – paragraph 2 – point b
(b) to carry out appropriate 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; n request of competent authorities on samples collected during market surveillance activities under article 65 and of notified bodies on samples collected during unannounced inspections under Annex VIII section 4.4;
Amendment 391 #
Proposal for a regulation
Annex 8 – section 2 – point 6 – point 6.2 – point c
Annex 8 – section 2 – point 6 – point 6.2 – point c
(c) For companion diagnostic intended to be used to assess the patient eligibility to a treatment with a specific medicinal productBefore issuing an EU design- examination certificate, the notified body shall consult brequest a refoere issuing an EU design-examination certificate and on the basis of the draft summary of safety and performance and the draft instructions for use, one of the competent authorities designated by the Member States in accnce laboratory, where designated in accordance with Article 78, to verify compliance of the device with the CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and perfordmance with Directive 2001/83/EC (that is at least equivalent. The reinafter referred to as ‘medicinal products competent authority’) or the European Medicines Agency (hereinafter referred to as ‘EMA’) establishference laboratory shall provide a scientific opinion within 30 days. The scientific opinion of the reference laboratory and any possible updates shall be included byin the Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, regarddocumentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed ing the suitability of the device in relation to tcientific opinion when medicinal product concerned. Where the medicinal product falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the EMAaking its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable.
Amendment 392 #
Proposal for a regulation
Annex 8 – section 2 – point 6 – point 6.2 – point c a (new)
Annex 8 – section 2 – point 6 – point 6.2 – point c a (new)
(c a) Changes to the approved design shall receive further approval from the notified body which issued the EU design- examination certificate, wherever the changes could affect conformity with the general safety and performance requirements of this Regulation or with the conditions prescribed for use of the device. The applicant shall inform the notified body which issued the EU design- examination certificate of any planned changes to the approved design. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU design-examination report. Where the changes could affect compliance with the CTS or with other solutions chosen by the manufacturer which were approved through the EU design examination certificate, the notified body shall consult the reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained. The reference laboratory shall provide a scientific opinion within 30 days. The approval of any change to the approved design shall take the form of a supplement to the EU design-examination certificate.
Amendment 394 #
Proposal for a regulation
Annex 9 – point 3 – paragraph 1 – point 3.5
Annex 9 – point 3 – paragraph 1 – point 3.5
3.5. in the case of devices classified as class D, or for companion diagnostics, request a reference laboratory, where designated in accordance with Article 78, to verify compliance of the device with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The reference laboratory shall provide a scientific opinion within 30 days. The scientific opinion of the reference laboratory and any possible update shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable;
Amendment 395 #
Proposal for a regulation
Annex 9 – point 3 – paragraph 1 – point 3.6
Annex 9 – point 3 – paragraph 1 – point 3.6
Amendment 396 #
Proposal for a regulation
Annex 9 – point 5 – point 5.4
Annex 9 – point 5 – point 5.4