Medical devices within the EU are currently regulated by 3 directives

• Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
• Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
• Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)

In addition, the Commission has adopted several implementing measures that concern, among other things, medical devices manufactured using tissues of animal origin, the classification of certain medical devices, and common technical specifications for in vitro diagnostic devices (IVDs), listed in annex II of the IVD directive. Please click here for more information.

Cyprus, for European acquis harmonisation, approved (only in Greek):

• Essential Requirements that Certain Categories of Products should fulfil Laws of 2002 to 2013
• Essential Requirements (Medical Devices) Regulations of 2003 to 2013
• Essential Requirements (Active Implantable Medical Devices) Regulations of 2003 to 2009
• Essential requirement (in Vitro Medical devices) Regulations of 2003

In September 2012, the European Commission adopted two new Regulations:

• Regulation (EU) 2017/745 on medical devices, and
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices

The deadline for full implementation of Regulation (EU) 2017/745 is May 2020, while Regulation (EU) 2017/746 has a longer deadline, until May 2022.

At the same time, in accordance with Article 105 of Regulation 745/2017, the Medical Device Coordination Group in order to ensure a uniform application of the relevant regulations provision within the EU, has adopted a number of non-binding legal documents. Please click here for more information.