What do I do if the device I want to purchase isn't CE marked ?
Since the 14th June, all medical devices placed on the market must be bear the CE mark. The only exceptions are allowed by the Commission Decision 98/C 242/05, for those products already in the supply chain (i.e., manufactured before this date and shipped to distributors etc).
However, certain products are still not CE marked, either because the manufacturer has taken a decision not to CE mark them (if, for example their European market is too small), or because they are ignorant of the legislation (very few manufacturers are now unaware of the Directive).
As it is now illegal to place on the market a medical device which isn't CE marked, any manufacturer doing so is committing an offence. It is not against the directive for someone to purchase a non-CE marked device, but the medical device itself would be in breach of the law. If an incident occurred, and subsequent investigation found that the device involved did not comply with current legislation (i.e., was not CE marked), the purchaser could be found to be liable.
Therefore, if an NHS Trust wishes to purchase a non-CE marked device, they should take legal advice before purchasing the device as to the potential implications for the Trust.
The MHRA should be informed of any medical devices which are not CE marked.
Author: Pete Phillips.