Guidelines relating to medical devices Directives

The guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health.

They have been carefully drafted through a process of consultation with various interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, they reflect positions taken in particular by representatives of Competent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the medical devices sector.

The guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.

Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions. Guidelines are subject of a regular updating process

2.11 Products using materials of biological origin	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		2.11/1 rev.2	01-2008
	Annex 1

2.12 Market surveillance	Medical devices vigilance system Manufacturer Incident Report - Field Safety Corrective Action  (Word versions)		2.12/1 rev.5	04-2007
	Appendix,list of contact points		2.12/1 rev.4	11-2001
	Clinical Evaluation - Post Market Clinical Follow-up		2.12/2	05-2004