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Medical Device Regulation: Technical File Requirements

There is a concern that many manufacturers who CE mark class I medical devices do not have adequate technical (safety) data to provide in the event of a European complaint, regulatory or vigilance enquiry. The fact that class I devices are “self-certified” does not absolve the manufacturer from having sufficient technical and safety data to support their marketing activities in the EU.

In addition, as from mid-year (probably May / June), anyone who exports medical devices into the EU may have to assure that their importer, and authorised representative (such as ourselves), has suitable access to the company technical documentation to demonstrate conformity to the regulations. So, in that respect, importers and authorised representatives could be asked to show how they can gain access to device technical files in a timely manner. To not be able to do this could mean exposure to legal issues and, in particular product liability claims, as all economic operators could be held liable to assure device conformity.

We strongly urge these processes to be considered as soon as possible before the new EU regulations are upon you;

  1. Assure you have up-to-date, signed and approved regulatory files that are reviewed for completeness. Such files should concentrate on safety (by risk management) and a demonstration of conformity to the EU “Essential Requirements” (Now called “General Safety and Performance Requirements” in the Regulations) by using a check list. All manufacturers selling in the EU must have a suitable “Declaration of Conformity”. If you are an Advena Ltd. Authorised Representative client you will know we insist on the latter before we will contract with you.
  2. Assure that your importers (that is the businesses who first bring your devices into the EU – you may have several) understand their responsibilities for being able to access your technical data.

NOTE:    Having access to technical files does not mean the economic operator having the information physically on file in their premises, although this may be the way you want to work.  As most technical file documents are live, and subject to continual improvement and update, this information could be on a cloud server with permission to be being given in the event of a regulatory enquiry. However, Authorised Representatives must be able to show they have verified that the text is available and complete.

Any Non-EU medical devices manufacturers seeking an EU Authorised Representative (EC REP) should contact Advena Limited by email: info@advenmedical.com to request detailed information about our services and a quotation.

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