MME News

In the MME News of last March, we sent a warning that Annex IX of the Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC which places a special emphasis on a new definition of a device’s time of use might lead to some reclassification of devices. The new classification guidelines MEDDEV 2. 4/1 Rev. 9 of June 2010, published 3 months after the enter in force of the amended MD directive (and not before as it should have been! ) confirm this vision.
You will read below (…)

Medical device manufacturers are required to comply with Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC by 21 March 2010. Despite having made every effort to meet the essential requirements, companies may be surprised to learn that the classification of some of their devices may be challenged. Specifically, Annex IX of the directive places a special emphasis on a new definition of a device’s time of use. The implications of this shift for manufacturers were discussed (…)

The end of 2009 turned out to be a very prolific period for the publication of new or updated guidelines. The documents published in December explain or incorporate changes introduced by Directive 2007/47/EC amending Council Directive 90/385/EEC and Council Directive 93/42/EEC, which will be applicable on March 21, 2010. The first issue of the MediMark Europe News in 2010 seems like a perfect opportunity to raise awareness of three new EC guidelines related to quality systems.

In our previous edition, we published a comprehensive glossary of revisions to Medical Device Directive 93/42/EEC and Active Implantable Medical Device Directive 90/385/EEC. In this issue, we focus on changes which may affect your currents labels and Instructions for Use (IFU). Knowing the delay for translation and printing, it is time to prepare your mandatory revisions which will become law on 21 March 2010.

The most important changes are the requirements of clinical data and design documentation for all classes of devices. It will particularly concern the manufacturers of class IIa devices because they are audited by a Notified Body. However, manufacturers of Class I devices are also concerned through their ISO 13485:2003 audit or when a competent authority makes an inspection of the technical files at the European authorized representative premises. Guidance documents and secondary legislation (…)

For many years, medical device manufacturers primarily used bar codes internally to track products as they moved from manufacturing facilities to labeling sites to distribution centers. Then, regulatory bodies began requesting bar codes to be placed on devices for reimbursement purposes. More recently, some of Europe’s national competent authorities (CAs) have lobbied for the implementation of bar coding in their country for traceability and patient safety reasons. Clearly, a pattern is (…)