Last September, a new medical-device directive — 2007/47/EC — was approved, clarifying and updating the current medical-device directive (MDD) and active implantable medical devices directive (AIMD).

The new directive, which has implications not only for manufacturers that sell medical devices in the European Union (EU) but also for the medical device industry as a whole, "modifies several key issues regarding medical devices and amends three significant medical device directives," according to Obelis European Authorized Representative Center (O.E.A.R.C.), which serves as an authorized representative for non-EU manufacturers.

In very few industries is the importance of product safety as crucial as it is in the design and manufacture of medical devices. "It is important that manufacturers understand their new responsibilities to guarantee their proper compliance in the EU," the O.E.A.R.C. says.

Manufacturers should be aware of several essential changes if they hope to ensure compliance with the new EU regulations. Here are just a few:

1) Manufacturers will be required to "designate a European-authorized representative for all classes of medical devices and the same one for the same category of medical devices ('single authorized representative')," notes the O.E.A.R.C. The manufacturer will appoint the authorized representative, who will deal with the compliance of devices in relation to the directives.

2) For the first time, software intended for use by the manufacturer for medical purposes (e.g., diagnostic or therapeutic purposes) will be classified as a medical device. Further, if the software is a stand-alone or is incorporated in a device, software validation is required. As such, many software designers will have to have their products CE Marked prior to release in Europe.

3) In 2010, clinical data will be required for ALL devices, regardless of classification. Moreover, regulatory data in accordance with the directive will have to be stored in a European databank accessible to "the competent authorities." "This regulatory data includes information on registration, vigilance reports and certificates as well as data relating to clinical investigations," according to the O.E.A.R.C.

4) Under the new directive, custom-device manufacturers will be subject to a post-market production review system involving incident reporting to the authorities. This means that companies "will have to keep close tabs on their products and have a system in place to report, and react to, any unexpected changes once their products are released into the marketplace," says Medical Design magazine.

5) Classification rules and definitions have changed. For one, medical devices in 2010 will be classified by their primary mode of action and not by intended use. Also: the definition of the central circulatory system has now been expanded; devices that use human tissue, blood and plasma will fall under the scope of Directive 2001/83/EC and will be classified as Class III; and all surgically invasive devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body will also be classified as Class III devices.

"In just over 18 months, companies that currently have a CE Marking, or are trying to earn a CE Marking for new products, may face unnecessary delays or even lose certification if they're not taking steps to ensure they comply with the new requirements," warned Medical Design magazine in June.

"Many of the changes are significant and can't be made overnight," Claire McKenna, Medical Device Program Manager with the National Standards Authority of Ireland Inc., told Medical Design magazine. "Companies must start looking at their products in a way to ensure they have the correct data and systems in place come 2010."

Visit the O.E.A.R.C. for the complete list of changes. And see Medical Design's coverage for more tips.

See also: Quality & Regulatory Compliance: Who's Responsible?

Resources

Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007
Official Journal of the European Union, Sept. 21, 2007

The Latest EU Regulatory Developments
by Miguel Ohn
Obelis European Authorized Representative Center

Is Your Company Ready for the 2010 Medical Device Directives?
Medical Design, June 1, 2008