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In Vitro Devices En

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EDPS in vitro devices
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    Postal address: rue Wiertz 60 - B-1047 Brussels Offices: rue Montoyer 30 E-mail : edps@edps.europa.eu - Website: www.edps.europa.eu  Tel.: 02-283 19 00 - Fax : 02-283 19 50   Opinion of the European Data Protection Supervisor on the Commission proposals for a Regulation on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and a Regulation on in vitro diagnostic medical devices THE EUROPEAN DATA PROTECTION SUPERVISOR, Having regard to the Treaty on the Functioning of the European Union, and in  particular Article 16 thereof, Having regard to the Charter of Fundamental Rights of the European Union, and in  particular Articles 7 and 8 thereof, Having regard to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of  personal data and on the free movement of such data 1 , Having regard to Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the  processing of personal d ata by the Community institutions and bodies and on the free movement of such data 2 , and in particular Article 28(2) thereof, HAS ADOPTED THE FOLLOWING OPINION: 1. INTRODUCTION 1.1. Consultation of the EDPS 1.   On 26 September 2012, the Commission adopted two proposals for Regulations on medical devices (‘the proposed MD Regulation’) 3 , and a Regulation on in vitro diagnostic medical devices (‘the proposed IVD Regulation’) 4 . These proposals were sent to the EDPS for consultation on 2 October 2012. 2.   The EDPS welcomes the fact that he is consulted by the Commission and recommends that a reference to the consultation be included in the preambles of the proposed Regulations. 1  OJ L 281, 23.11.1995, p. 31. 2  OJ L 8, 12.1.2001, p. 1. 3  COM (2012) 542 final. 4  COM (2012) 541 final.   2 1.2. Objectives and scope of the proposed Regulation 3.   The proposed Regulations aim at ensuring the saf ety of medical devices (‘MDs’) 5  and in vitro diagnostic medical devices (‘IVDs’) 6  and their free circulation within the internal market. They amend and clarify the scope of the existing legislation, to take into account scientific and technological progress. The proposed Regulations contain legal frameworks to utilize an existing electronic database (Eudamed database) 7  at EU level to facilitate coordination between authorities to ensure rapid and consistent responses to safety issues, to increase devices traceability throughout the supply chain and to clarify the obligations and responsibilities of manufacturers, importers and distributors. They furthermore strengthen the different levels of supervision by clarifying and enhancing the  position and powers of public authorities vis-à-vis economic actors. 1.3. Aim of the EDPS Opinion 4.   The proposed Regulations will affect the rights of individuals related to the  processing of their personal data. Amongst other issues, they deal with the  processing of sensitive data (health data), a central EU-level database which includes personal data, market surveillance 8  and record keeping. 5.   The EDPS welcomes that the Commission has made an effort to guarantee the correct application of EU rules concerning the protection of personal data in the  proposed Regulations. However, the EDPS sees a need for some clarifications with particular regards to sensitive data, especially when this category of personal data comes to the processing and storage in the database suggested by the  proposed Regulations. Indeed the EDPS has identified certain ambiguities and inconsistencies in the way the proposed Regulations deal with the issue of whether and what categories of personal data will be processed, in particular where sensitive data regarding health might be processed and stored. 2. ANALYSIS OF THE PROPOSAL 2.1. Applicability of data protection legislation 6.   Several Recitals and provisions of the proposed Regulations mention Articles 7 and 8 of the Charter of Fundamental Rights, Directive 95/46/EC and Regulation (EC) No 45/2001 9 . 5  Medical devices include products such as sticking plasters, contact lenses, dental filling materials, x-ray machines, pacemakers, breast implants or hip replacements. 6  In vitro diagnostic medical devices include products such as devices used to ensure the safety of  blood transfusion (e.g. blood grouping), detect infectious diseases (e.g. HIV), monitor diseases (e.g. diabetes) and perform blood chemistry (e.g. cholesterol measurement). 7  Established by Commission Decision 2010/227/EU, OJ L 102, 23.4.2010, p. 45. 8  For example regarding the market surveillance plan, where manufacturers are required to institute and keep up to date a systematic procedure to collect and review experience gained from devices placed on the market. This would entail the collection, recording and investigation of complaints and reports from healthcare professionals, patients or users on suspected incidents related to devices. 9  See for example Articles 24, 27, 44, 52, 84, 85 and Recitals 38, 48 and 63 in the proposed MD Regulation, and see for example Articles 22, 42, 50, 80 and 81 and Recitals 31, 44, and 59 in the  proposed IVD Regulation.   3 7.   In particular, Article 85 of the proposed MD Regulation and Article 81 of the  proposed IVD Regulation state that Member States shall apply Directive 95/46/EC to the processing of personal data pursuant to the proposed Regulations and that Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to the proposed Regulations. 8.   The EDPS welcomes these provisions and only recommends that both Articles clarify the reference to Directive 95/46/EC by specifying that the provisions will apply in accordance with the national rules which implement Directive 95/46/EC. 9.   The references to data protection law are relevant, for example, in relation to the various provisions concerning exchanges of personal data between national authorities and the Commission (to and from the Eudamed database). These  provisions need to be applied in a way which is consistent with data protection legislation, in particular by allowing a selective and proportionate exchange of  personal information, where necessary, on a basis of more precise provisions which cannot  be construed as a blanket authorisation to exchange all kind of  personal data 10 . 2.2. Processing of personal data concerning health 10.   Clinical investigations 11  and reporting of incidents involving MDs and IVDs (vigilance) activities as well as market surveillance activities regarding MDs and IVDs are by nature dependent on the processing and storage of data at different levels (local, national and European). Personal data of identified or identifiable  patients participating in clinical investigations and vigilance can be considered as data relating to health (‘health data’) of the persons concerned since they reveal information about medical procedures and associated health problems. 11.   Processing of such data is subject to strict data protection rules as laid down in Article 8 of Directive 95/46/EC (and its implementing national laws) and Article 10 of Regulation (EC) No 45/2001. Among the grounds which allow for  processing of personal data relating to health, Article 8(3) of Directive 95/46/EC and Article 10(3) of Regulation (EC) No 45/2001 are applicable in this case. These provisions lift the prohibition of processing health related data if the  processing is ‘required for the purpose of preventive medicine [...] ’ . The EDPS wishes to underline that this sets a high standard. 12.   The importance of protecting such data has repeatedly been emphasised by the European Court of Human Rights in the context of Article 8 of the European Convention of Human Rights. The Court has stated: ‘ The protection of personal data, in particular medical data, is of fundamental importance to a person’s 10  The proposed Regulations contain provisions allowing or requiring national authorities to exchange information between them and the Commission. In particular, the Articles concerning the Eudamed database and the information to be included in this database. 11  Called clinical investigations under the proposed MD Regulation, defined in Article 2(33) as ‘any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device´ and called clinical performance studies under the proposed IVD Regulation, defined in Article 2(33) as `a study undertaken to establish or confirm the clinical performance of a device´.   4 enjoyment of his or her right t o respect for private and family life as guaranteed by Article 8 of the Convention ’ 12 . 13.   The EDPS therefore recommends inserting in Article 85 of the proposed MD Regulation and in Article 81 of the proposed IVD Regulation explicit reference to Article 8 of Directive 95/46/EC and Article 10 of Regulation (EC) No 45/2001. 2.3. The Eudamed database  14.   The Eudamed database is regulated in Article 27 of the proposed MD Regulation and Article 25 of the proposed IVD Regulation. 15.   The purposes of the Eudamed database are listed in Article 27 of the proposed MD Regulation as: (a) to enable the public to be adequately informed about devices placed on the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators; (b) to enable traceability of devices within the internal market; (c) to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to be conducted in more than one Member State to comply with information obligations; (d) to enable manufacturers to comply with information obligations... [regarding vigilance and market surveillance]; (e) to enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well informed basis and to enhance the cooperation between them. 16.   According to Article 27(2) of the proposed MD Regulation and Article 25 of the  proposed IVD Regulation, the Eudamed database shall include the following modules as integral parts: (a) the electronic system on Unique Device Identification; (b) the electronic system on registration of devices and economic operators; (c) the electronic system on information on certificates; (d) the electronic system on clinical investigations 13 ; (e) the electronic system on vigilance; (f) the electronic system on market surveillance. 12  See ECHR 17 July 2008, I v Finland (appl. No 20511/03), paragraph 38 and ECHR 25 November 2008,  Armonas v Lithuania  (appl. No 36919/02), paragraph 40. 13  The electronic system on interventional clinical performance studies and clinical performance studies involving risks for the subjects for IVDs.

Manual de JD

Jul 23, 2017
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