Basic legislation
New Regulations for Medical Devices
• REGULATION (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (application date: 26 May 2021)
• REGULATION (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (application date: 26 May 2022)
Legislation that has been replaced by the New Regulations
• Directive 93/42/EEC for Medical Devices: Harmonization of National Legislation: DY8d/G.P.oik130648/Government Gazette 2198B/02-10-2009
• Directive 90/385/EEC for Active Implantable Medical Devices: Harmonization of National Legislation: δΥ8δ/Γ.Π.οικ130644/ΦΕΚ 2197Β/02-10-2009
• Directive 98/79/EC for In Vitro Diagnostic Medical Devices: Harmonization: δΥ8δ/οικ3607/892/ΦΕΚ 1060Β'/10-8-01
Additional national legislation
• Decision of the Board of Directors/EOF No. 6209/2009 (Government Gazette 199Β'/06.02.2009): Specifications for Good Manufacturing Practices for Medical Devices
• Ministerial Decision: DY8d/G.P.oik./1348/Government Gazette 32/Β΄/16-1-2004 (Principles and guidelines for good practice in the distribution of I/P)
• Law No. 3370/Government Gazette A176/11-7-2005 (Amendment of Law 1316/1983 – Readiness Fee)
• DYG3a/G.P 139307/05/ GG 1098/Β΄/10-8-2006 Ministerial Decision on fees
Note: For more information about the new Regulations and their implementation, please refer to the European Commission website at the following links:
//health.ec.europa.eu/medical-devices-sector_en
//health.ec.europa.eu/medical-devices-sector/new-regulations_en
