The Medical Devices Expert Group (MDEG) endorsed a new set of guidance document during its meeting on 10 January 2012.

The new set includes the following guidance documents:

• MEDDEV 2.12-1 rev.: Guidelines on a Medical Device Vigilance system

Update of the manufacturer Incident Report Form and the Field Safety Corrective Action (FSCA) Form (annex 3 & 4), and introduction of templates for manufacturer Trend Reporting and manufacturer Periodic Summary Reporting.

• MEDDEV 2.12-2 rev.2: Guidance on Post Market Clinical Follow up studies, a guide for manufacturers and Notified Bodies

Replacing MEDDEV 2.12-2 (Clinical Evaluation - Post Market Clinical; follow-up dated May 2004)

• MEDDEV 2.5/10: Guideline for Authorised representatives
• MEDDEV 2.14/1 rev.2 on IVD Medical Device - Borderline and Classification issues

The issue is whether a device used for the collection of specimen which will then be used with an IVD shall or shall not follow the Medical Devices Directive.

• Guideline on the qualification & classification of standalone software used in healthcare within the regulatory framework for medical devices
• Guideline for the CE marking of blood based in vitro diagnostic medical devices for vCJD (variant Creutzfeldt-Jakob disease) based on detection of abnormal Platelet-rich Plasma (PrP)

All guidelines will be published on the European Commission website shortly.

Eucomed welcomes these long awaited initiatives which should contribute to a better application of the Medical Devices Directives as modified by Directive 2007/47/EC.

The Medical Device Expert Group (MDEG) is a group established by the European Commission and is composed of delegates from member state competent authorities and other stakeholders such as Eucomed, EDMA, CEN and NB-MED. The MDEG meets regularly to discuss common issues and discusses the drafting of new guidance documents. They reflect the consensus position of its members on issues such as the demarcation between the Medical Device Directive and AIMDD Directive, definition of an accessory, classification of devices and translation procedures.

If you have any questions, please contact dario.pirovano@eucomed.org.