New MEDDEV Documents Released

Three new MEDDEV documents have been released. The documents are a fantastic resource for medical device manufacturers placing product on the market or carrying out other related activities in the European Union. The documents are as follows:

1. Guidelines for Authorised Representatives – MEDDEV 2.5/10, January 2012

This document is designed to clarify the role of the Authorised Representative in the three Medical Device Directives.  The guideline indicates that it is vital to have a contract between the manufacturer and the Authorised Representative specifying the tasks and authorities the manufacturer will delegate to the Authorised Representative.

2. Guidelines on Post Market Clinical Follow Up Studies – MEDDEV 2.12/2 revision 2, January 2012

This document is intended to provide guidance on how to carry out post market clinical follow studies in order to fulfil post market surveillance requirements defined in the Medical Device Directives.

3. Guidelines on the Qualification and Classification of Stand Alone Software used in Healthcare within the Regulatory Framework of Medical Devices – MEDDEV 2.1/6, January 2012

This document defines the criteria for qualification of stand alone software when used in a healthcare setting as a medical device. The guidance provides information relating to the application of the classification criteria which relates to stand alone software.

For a copy of any of the above MEDDEV guidance documents, contact KD&A.