Guidance | Medicaldevice

The MEDDEVs promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures.

The MEDDEVs are drafted by authorities charged with safeguarding public health in conjunction with all stakeholders (industry associations, health professionals associations, notified bodies and European standardisation organisations). This is in accordance with the relevant annexes of the directives
MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process
These documents have particular reference codes and are endorsed at the medical devices expert group (MDEG) plenary meetings
The guidelines are not legally binding. However, due to the participation of the aforementioned interested parties and the experts from competent authorities, it is expected that the guidelines be followed, ensuring the uniform application of relevant directive provisions.

Guidance for manufacturers of class Ⅰ medical devices (52 kB) endorsed by the MDEG on December 2009
Guidance for manufacturers of custom-made medical devices (51 kB) endorsed by the MDEG on June 2010
Guidance on Dir. 2005/50/EC (32 kB) endorsed by the MDEG on December 2006
IVD trisomy 21 (13 kB) endorsed by the MDEG on December 2006
IVD rare blood groups (20 kB) endorsed by the MDEG on December 2003

Info on placing medical devices on the market (16 November 2010, 30 kB)
Information on medical devices Customs Union agreement with Turkey (11 February 2010, 32 kB)
Decision No 1/2006 of the EC-Turkey Association Council of 15 May 2006 on the implementation of Article 9 of Decision No 1/95 of the EC-Turkey Association Council on implementing the final phase of the Customs Union
Statement of Turkey – EC Customs Union Joint Committee on the implementation of article 1 of Decision 1/2006 (88 kB)
Info on 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, 21 kB)
Info on the relation between the revised Directive 93/42/EEC and Directive 89/686/EEC on personal protective equipment (21 August 2009, 28 kB)
Info on implementation of Directive 2007/47/EC amending directives 90/385/EEC, 9342/EEC and 98/8/EC (5 June 2009, 35 kB)
Info on the medical devices directives for medical device own brand labellers (4 February 2008, 17 kB)