MEDDEV és NB-MED dokumentumok

1. MEDDEV és NB-MED dokumentumok Dárday Vilmos orvostechnikai szakértő 2010. MEDDEV

2. Az orvostechnikai eszközök „lelőhelye” az Európai Unió honlapján: • http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm • (2010. januári állapot szerint) • Az Enterprise and Industry Főigazgatóság (Direktoriátus) anyagán belül. • A Reference documents lelőhelye: • http://ec.europa.eu/enterprise/sectors/medical-devices/documents/index_en.htm • Az innen elérhető dokumentum-féleségek (csoportok): • Jogszabály erejű dokumentumok (Direktívák, stb.) • 2. Útmutatók (MEDDEV dokumentumok) • 3. Consensus statements (Egyetértő megállapítások) • 4. Értelmező dokumentumok • 5. Szabványok (harmonizált) MEDDEV

3. 1. Jogszabályi erejű dokumentumok • Ezen a címen a következő dokumentumok találhatók meg: • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices • - Commission Decision 2002/364/EC - OJ L131/17 of 16.05.2002 (CTS régi) • - Commission Decision 2009/886/EC - OJ L318/25 of 14.12.2009 (CTS új) • - Directive 2003/32/EC - OJ L105/18 of 26.04.2003 (animal tissues) • - Directive 2005/50/EC - OJ L 210/41 of 12/08/2005 (hip, knee, shoulder) • - Directive 2003/12/EC - OJ L 28/43 of 4.02.2003 (brerast implants) MEDDEV

4. 2. Útmutatók (MEDDEV dokumentumok) – 1. Számozásuk a Direktíva számozásához igazodik. Közülük több megjelent magyarul, az „Orvos- és Kórháztechniká”-ban. 2.1 Scope, field of application, definition MEDDEV 2.1/1 Definitions of "medical devices", "accessory" and "manufacturer„ MEDDEV 2.1/2 rev.2 Field of application of directive "active implantable medical devices" MEDDEV 2.1/2.1 Interface with other directives - Medical devices/medicinal products – 1998. február MEDDEV 2.1/3 rev.2 Interface with other directives - Medical devices/medicinal products MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative - December 2009 MEDDEV

5. 2. Útmutatók (MEDDEV dokumentumok) – 2. (folytatás) MEDDEV 2.1/4 Interface with other directives - Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective  equipment MEDDEV 2.1/5 Medical devices with a measuring function 2.2. Essential requirements MEDDEV 2.2/1 rev.1 EMC requirements MEDDEV 2.2/3 rev.3 "Use by" - date 2.4. Classification MD MEDDEV 2.4/1 rev.8 Part 1 MEDDEV 2.4/1 rev.8 Part 2 MEDDEV

6. 2. Útmutatók (MEDDEV dokumentumok) – 3. (folytatás) 2.5. Conformity assessment procedure (general and particular) Regulatory auditing of quality systems of medical device manufacturers(See document in the GHTF-Global Harmonization Task Force website) MEDDEV 2.5/3 rev.2 Subcontracting quality systems related MEDDEV 2.5/5 rev.3 Translation procedure MEDDEV 2.5/6 rev.1 Homogenous batches (verification of manufacturers' products) MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants Evaluation of medical devices incorporating products of animal origin.(See MEDDEV 2.11/1 rev.2) MEDDEV 2.5/9 rev.1 Evaluation of medical devices incorporating products containing natural rubber latex MEDDEV

7. 2. Útmutatók (MEDDEV dokumentumok) – 4. (folytatás) 2.7. Clinical investigation, clinical evaluation MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified bodies Appendix 1: Clinical evaluation on coronary stents MEDDEV 2.7/2 Guide for Competent Authorities in making an assessment of clinical investigation; notification 2.10. Notified Bodies MEDDEV 2.10/2 rev.1 Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices Annex 1Annex 3 Annex 2Annex 4 MEDDEV

8. 2. Útmutatók (MEDDEV dokumentumok) – 5. (folytatás) 2.11. Products using materials of biological origin MEDDEV 2.11/1 rev.2 Application of Council Directive 93/42/EEC taking into account the Commission Directive 2003/32/EC for Medical Devices utilising tissues or derivatives originating from animals for which a TSE risk is suspected Annex 1 2.12. Market surveillance MEDDEV 2.12/1 rev.6 Medical devices vigilance system (December 2009) Manufacturer Incident Report Field Safety Corrective Action List of contact points MEDDEV 2.12/2 Clinical Evaluation - Post Market Clinical Follow-up MEDDEV

9. 2. Útmutatók (MEDDEV dokumentumok) – 6. (folytatás) 2.13. Transitional period MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009 2.14. IVD issues MEDDEV 2.14/1 rev.1 Borderline issues MEDDEV 2.14/2 rev.1 Research Use Only products MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 102.15. Other guidances MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the Medical Device Directives MEDDEV

10. 3. Consensus statements (Egyetértő megállapítások) Guidance Notes for Manufacturers of Class I Medical Devices endorsed by the Medical Devices Expert Group (MDEG) on December 2009 Guidance Notes for Manufacturers of Custom-Made Medical Devices endorsed by the MDEG on December 2007 Guidance document on Dir. 2005/50/EC endorsed by the MDEG on December 2006 IVD Trisomy 21 endorsed by the MDEG on December 2006 IVD Rare Blood Groups endorsed by the MDEG on December 2003 4. Értelmező dokumentumok Interpretation of the relation between the revised Directives 90/385/EEC and 93/42/EEC concerning (active implantable) medical devices and Directive 2006/42/EC on machinery (21 August 2009) Interpretation of the Medical Devices Directives in relation to medical device own brand labellers (4 February 2008) MEDDEV

11. 4. Értelmező dokumentumok (folytatás) Interpretation of the relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment (21 August 2009) Interpretative document of the Commission's services implementation of directive 2007/47/EC amending directives 90/385/EEC, 9342/EEC and 98/8/EC (5 June 2009) 5. (Harmonizált) szabványok Harmonised Standards Elérhetőségek külön prezentációban is. CEN monthly Snapshot Hasznos linkek listája http://ec.europa.eu/enterprise/sectors/medical-devices/links/index_en.htm MEDDEV