Medical Device Consulting Regulatory Quality Complaince

Not just for the EU - CER is Global

Standardized Technical Documents

You will have noticed that regulatory agencies around the world are becoming standardized. The Global Harmonization Task Force commenced work in 1993 with the objective to achieve harmonisation in medical device regulatory practices with a view to address the following topics:

  1. essential principles of safety and performance of medical devices on a global basis;
  2. the role of standards in the assessment of medical devices;
  3. comparison of device adverse reporting systems in the European Union, United States, Japan, Canada and Australia;
  4. the management of information related to medical device vigilance reporting;
  5. adverse event reporting rules for device manufacturers, including minimum data sets for manufacturer reporting to competent authorities;
  6. design control guidance for medical devices; and
  7. guidelines for regulatory auditing of quality systems of medical device manufacturers.

From the GHTF, governments around the world are co-operating to share information and reach common operating approaches to the management of medical devices. As one example of this see: the International Medical Device Regulators Forum.

Governments are moving to a common understanding of the type of documents that they want to see when Companies submit applications for approval of medical devices. They have similar process requirements for data relating to devices failures and complaints.

The CER is Really Not Just for the EU

Seeing the CER as a purely EU requirement is not cost effective. All markets need some form of documentation to support the risk-benefit ratio associated with the device. It makes sense to have one document set meet the requirements for all markets.

Even the United States is now recognizing International Standards; these standards drive to a common set of tests being conducted as part of product development. Governments have a common understanding to what to expect in a submission. Companies are increasingly moving to external, independent, testing houses to conduct device validation testing. The testing laboratories have expertise and an independence in reporting the result that encourages faith in the results.

CER need to be both established and then maintained. The requirement for Post Market Surveillance in the EU is being matched by an increasing enforcement by the FDA in term of maintaining the Design History Files of 510k devices ( DHF have always had to be "maintained" but enforcement on 510k devices is increasing - PMA DHF were already more heavily reviewed).