Medical Device Regulation in USA is formulated and controlled by FDA via Section 510k of the act. However, in Europe its via MDD directive so called CE Marking
Reading this article will help those unfamiliar with 510k and CE marking effectively prioritize their regulatory efforts.
510(k) is the preferred route to reach the Largest single market (USA) whereas CE Marking is the preferred route to reach 37 European counties and very interestingly it is widely accepted in Australia, Middle east and Asia pacific Counties.
Do not be the impression that once the 510(k) is in place it will be easy to obtain a CE Mark. Understand there are differences in the process and compliance procedures. The medical device classification based on the risk itself is different In 510k the classification is Class 1, Class 11 & Class 111 whereas in CE Marking its starts from Class 1, Class 1a, Class 1m, Class 11a, Class 11b and Class 111.
510k referred either abbreviated or traditional methods for meeting the compliance requirement, whereas CE Marking the manufacturer must demonstrate their device complies with one of the European Union’s Directives related to ‘medical’ products: the Medical Device Directive (93/42/EEC), the In-Vitro Diagnostic Medical Device Directive (98/79/EC), or the Active implantable Medical Device directive (90/385/EEC).
US has a mechanism the regulatory authority (Food & Drug Administration) itself controls review approval and inspection for the devices planning to market whereas in Europe each Member State in the European Union has a Competent Authority. These competent authorities appointed Notified Bodies responsible for review approval and inspection for the devices as per CE marking directives.
The FDA 510k and CE Marking process starts with understanding the class of the device. Class 1 device exempted from 510k and similarly exempted by notified body certification
Once you identified the class and predicative device followed by product testing, 510k preparation has to be started and 510(k) application is submitted to CRDH/FDA along with 510k submission File. Whereas CE Marking Technical File to be prepared and submitted to Notified Body.
Class I devices without a measuring function and which are not sterilized do not need to be audited. The manufacturer can self-declare and place on the market with appropriate documentation.
During the review period the clients has the time period to implement QMS/ GMP in the organization. For FDA insists for Implementing 21 CFR 820 (GMP) whereas MDD CE Marking it is mandatory to Implement EN ISO 13485.
For manufacturers cleared 510k need not want to face any onsite audit before listing. In the case of CE Marking usually requires at least two audits a screening audit to review the QMS for compliance with EN ISO 13485 and the associated directive. A full-fledged onsite audit also known as certification audit will be carried out and based on successful completion CE Certificated is awarded.
If you are outside the EU, you must contract an ‘Authorized representative’ to act on your behalf, which is similar to the FDA’s requirement for an US Agent if you are a foreign importer of medical devices into the US.