EU High Court Rules that Assessors Must Investigate Claims that Medical Devices Fall Below Safety Standards

Case C-219/15 – Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH

Pinsent Masons reports that the EU’s highest court has ruled that organisations which assess whether medical devices are safe for people to use, must investigate claims that those devices fall short of safety standards where there is evidence to support concern. 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 will be subject to national law, rather than EU law whether notified bodies can be held liable for any harm caused due to oversight on their part. The Court was asked to consider these points following the referral of a case by a court in Germany.  Pinsent Masons reported on the AG opinion in this case here The German court will now interpret the CJEU’s ruling and determine whether Schmitt has a valid claim for damages.
To read Pinsent Mason’s comment on this story, please click here.
To read the Judgement of Court from the CJEU, pleas click here.
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Published on 2. March 2017 in News EU