Out-Law / Your Daily Need-To-Know

Assessors are duty bound to act where there is suspicion that medical devices fall below standards, says EU court

20 Feb 2017, 10:01 am

Organisations tasked with assessing whether medical devices are safe for people to use are duty bound to look into claims that those devices fall short of safety standards where there is evidence to support that concern, the EU's highest court has ruled.

However, the Court of Justice of the EU (CJEU) said that 'notified bodies' are not under a general obligation to "carry out unannounced inspections, to examine devices and/or to examine the manufacturer’s business records", although it is open to them to undertake such activity.

The CJEU also said that it is a matter of national, not EU, law whether notified bodies can be held liable for any harm done to medical device users as a result of any failings of oversight on their part.

The Court was asked to consider the extent of the obligations notified bodies have under EU medical devices legislation, as well as their liability for faults, in a case referred to it by a court in Germany.

The German court has been considering claims made by Elisabeth Schmitt against TÜV Rheinland, a notified body operating in Germany, that the body was responsible for failing to make adequate checks that materials used in breast implants conformed to standards specified in EU medical devices law. Schmitt has sued TÜV Rheinland, claiming €40,000 in damages and a declaration that that body was liable for any future material damage suffered.

In its ruling, the CJEU said that "in the face of evidence indicating that a medical device may not comply with the requirements laid down in [EU medical devices laws] the notified body must take all the steps necessary to ensure that it fulfils its obligations [under those laws]".

In practice, that means, among other things, "ensuring that the manufacturer duly fulfils the obligations imposed by the approved quality system and establishing, where appropriate, whether EC certification may be maintained", according to statement issued by the Court alongside its judgment.

The Court said that the purpose of a notified body's involvement in assessing whether medical devices conform to EU regulatory standards is "to protect the end users of medical devices". However, it said national law governs "the conditions under which culpable failure by that body to fulfil its obligations under the directive in connection with that procedure may give rise to liability on its part vis-à-vis those end users".

It is now up to the German court to interpret the CJEU's ruling and determine whether Schmitt has a valid claim for damages.