In Canada, the analagous organization is Health Canada. Similar rules and responsibilities to FDA.
The European system is somewhat different. All medical devices being marketed or placed into service in Europe must comply with the European Medical Device Directive (MDD) and carry a CE marking. Depending on the type of device and device classification (per the Directive), the product must be type tested to the appropriate European standard and test data and/or clinical data must be evaluated by a "Notified Body" for medical equipment before the CE Marking can be applied. There is at least one Notified Body for medical equipment in each European country, and any Notified Body you choose can do the work on behalf of all countries in the EU. Most products will also need to have a quality audit performed by a Notified Body at the manufacturer's facility. The product classifications are somewhat different from the FDA class I, II, and III, so you need to read the Directive carefully to find out how your device should be classified. Class I devices need little Notified Body oversight. Class IIa and IIb require quality audits and type approval, Class III equipment requires even more oversight and control. You can view the MDD here: http://www.newapproach.org/directiveList.asp Regards, Greg Galluccio Galluccio & Associates 1-516-641-2250 www.productapprovals.com ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
