The European Commission has now published guidance in the form of a MEDDEV (2.1/6) that will assist manufacturers and regulators in determining whether standalone software should be qualified as a medical device and therefore require CE marking under one of the Medical Devices Directives ("MDD"). 

Placing a product on the market as general software is not without risk and will also have implications for marketing claims.  A country-by-country approach should therefore be taken to check the legal status of software prior to launch in a specific national market. 

Whilst the MDD state that standalone software can be qualified as a medical device or an in vitro diagnostic ("IVD") (or as an accessory to an either), it does not clearly specify when this occurs. This has led to varying approaches among EU Member States creating unhelpful uncertainty for companies marketing software across the European Economic Area ("EEA").  With more and more software being developed specifically for use in the clinical environment, medical device qualification issues should now be a particular focus for all such software manufacturers or suppliers.  The MEDDEV provides clarity here but software manufacturers should remember that:

  • The guidance is not legally binding and so there is a risk some EU member states may take a stricter interpretation; and
  • Regulators may also be influenced by any similar software product marketed as a medical device in jurisdictions outside of the EEA, like the United States.

Some of the key principles in the MEDDEV include:

  • The manufacturer must intend the software to have a 'medical purpose';
  • The clinical risk related to a possible malfunctioning of the software is not a relevant criterion for qualification;
  • A 'medical purpose' for the MDD does not include calculation, analysis or evaluation of data which is not for the benefit of one or more patients;
  • Mere collection and transmission of data with no modification is not the type of functionality caught by the MDD;
  • Software intended to allow direct diagnosis or patient monitoring or treatment may be considered a medical device.

A link to the MEDDEV can be found here.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 25/01/2012.