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ARTICLE · 30 JANUARY 2012

When Does Software Become A Medical Device?

CMS Cameron McKenna Nabarro Olswang
Explore more from CMS Cameron McKenna Nabarro Olswang

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").

European UnionMedia, Telecoms, IT, Entertainment
Shuna Mason
Shuna Mason
Joanna Hook
Joanna Hook

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

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