Activities of Milan CABRNOCH related to 2012/0266(COD)
Plenary speeches (1)
In vitro diagnostic medical devices - Medical devices (debate)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
Amendments (24)
Amendment 150 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In situations in which a product is not conceived by its manufacturer to be used for medical purposes, its certification as an medical device cannot be required; likewise a product cannot be an accessory to a specific medical device if it is not specifically conceived by its manufacturer to enable or assist the intended purpose of the medical device.
Amendment 171 #
Proposal for a regulation
Recital 31
Recital 31
(31) The findings of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), established by Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC, in its scientific opinion of 15 April 2010 on the safety of reprocessed medical devices marketed for single-use, and of the Commission in its report of 27 August 2010 to the European Parliament and the Council on the issue of reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC, call for regulation of the reprocessing of single- use devices in order to ensure a high level of protection of health and safety whilst allowing this practice to further develop under clear conditions. By reprocessing a single-use device its intended purpose is modified and the reprocessor should therefore be considered the manufacturer of the reprocessed device. Those single-use medical devices which are known in advance to present a safety risk shall not be reprocessed. A list of devices presenting such a risk shall be drawn up.
Amendment 217 #
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 theclassification rules and 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. The essential elements of this Regulation, such as the general safety and performance requirements, elements included in the technical documentation and the minimum content of the EU declaration of conformity may only be modified 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 238 #
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 medical device(s) in view of its/their intended purpose(s)
Amendment 253 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 19 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 19 – introductory part
(19) ‘manufacturer’ means the natural or legal person who manufactures or fully refurbishes a devicis responsible for has a device designed, manufactured orthe manufacture, design, packaging and labelling of a device or who fully refurbished,s and markets that device under his name or trademark.
Amendment 257 #
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 healthf patients and which has the legal capacity to engage in such activities;
Amendment 283 #
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 297 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
Amendment 308 #
Proposal for a regulation
Article 8 – paragraph 8
Article 8 – paragraph 8
8. Manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that product into conformity, withdraw it or recall it, as appropriate. They shall inform the distributors, the importers and, where applicable, the authorised representative accordingly.
Amendment 326 #
Proposal for a regulation
Article 11 – paragraph 7
Article 11 – paragraph 7
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and his authorised representative and, if appropriate, take the necessary corrective action to bring that device into conformity, withdraw or recall it. 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 and, if applicable, the notified body that issued a certificate in accordance with Article 45 for the device in question, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 329 #
Proposal for a regulation
Article 11 – paragraph 9
Article 11 – paragraph 9
9. Importers shall, for the period referred to in Article 8(4), keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation and, if applicable, a copy of the relevant certificate including any supplement, issued in accordance with Article 45, can be made available to those authorities, upon request. By written mandate, the importer and the authorised representative for the device in question may agree that this obligation is delegated to the to the manufacturer or his authorised representative.
Amendment 330 #
Proposal for a regulation
Article 11 – paragraph 10
Article 11 – paragraph 10
10. Importers shall, in response to a request from a competent national authority, provide it withforward all the information and documentation necessary to demonstrate the conformity of a product from the manufacturer or his authorised representative. This obligation shall be considered fulfilled when the manufacturer or, where possible, the authorised representative for the device in question provides the required information. Importers shall cooperate with a competent national authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.
Amendment 341 #
Proposal for a regulation
Article 12 – paragraph 6
Article 12 – paragraph 6
6. DistributoImporters shall, in response to a request from a competent national authority, provide it withforward all the information and documentation necessary to demonstrate the conformity of a devicproduct from the manufacturer or his authorised representative. This obligation shall be considered fulfilled when the manufacturer or, where possible, the authorised representative for the device in question, where applicable, provides the required information. Distributors shall cooperate with competent national authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market.
Amendment 379 #
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. PAt least 28 calendar days prior to making the relabelled or repackaged device available, the distributor or importer referred to in paragraph 3 shall inform the manufacturer and the competent authority of the Member State where he plans to make the device available and, upon request, shall provide them with a sample or a mock-up of the relabelled or repackaged device, including any translated label and instructions for use. HWithin the same period of 28 calendar days, he shall submit to the competent authority a certificate, issued by a notified body referred to in Article 29, designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system complies with the requirements laid down in paragraph 3.
Amendment 382 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union, provided that the device does not feature on the list of devices that are unsuitable for reprocessing, 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 396 #
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. The Commission, by means of implementingdelegated acts, shall establish and regularly update a list of categories and groups of single- use devices that may not be reprocessed owing to a genuine risk to safety. Those delegated acts shall be adopted in accordance with Article 89. The Commission, by means of delegated acts, shall establish and regularly update a list of categories or groups of single-use devices for critical use which may be reprocessed in accordance with paragraph 3. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). 9.
Amendment 425 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The EU declaration of conformity shall state that fulfilment of the requirements specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall be tdranslafted into the an official Union language or languages required by the Member State(s) in which the device is made availablethat is acceptable to the notified body processing the declaration of conformity in accordance with Article 42.
Amendment 429 #
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
Amendment 439 #
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
Article 23 – paragraph 1 – introductory part
For devices, other than custom-made or investigational devices, economic operators shall be able to identify the following, for thea period referred to in Article 8(4)of 10 years:
Amendment 550 #
Proposal for a regulation
Article 42 – paragraph 11
Article 42 – paragraph 11
Amendment 558 #
Proposal for a regulation
Article 44
Article 44
Amendment 599 #
Proposal for a regulation
Article 45 – paragraph 1
Article 45 – paragraph 1
1. The certificates issued by the notified bodies in accordance with Annexes VIII, IX and X shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates is set out in Annex XII.
Amendment 792 #
Proposal for a regulation
Annex 1 – part III – point 19 – point 19.3 – point l
Annex 1 – part III – point 19 – point 19.3 – point l
(l) If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If the device is included on the list of single-use devices pursuant to Article 15(4), information to the effect that the device may not under any circumstances be reused. If in accordance with point c) of Section 19.1 no instructions for use are needed, the information shall be made available to the user upon request.
Amendment 794 #
Proposal for a regulation
Annex 2 – paragraph 1 – point 2 – point b
Annex 2 – paragraph 1 – point 2 – point b
(b) a list of the language variants for thenk to a list of Member States wherein which the device is envisaged to behas been marketed.