Categorie: Medical devices

Cour de Cassation refers PIP case to Paris Court of Appeal

On 10 October, the French Supreme Court ruled that the Court of Appeal in Aix-en-Provence had not sufficiently addressed the arguments of plaintiffs in the damages claim they have brought against TÜV Rheinland in relation to the defective PIP breast implants. It is another step in the complex litigation involving the illegal use of substandard silicone gel for the manufacturing of breast implants by the French company PIP. See for comments on the decision from

BGH decides on TÜV Rheinland’s liability

The highest German court in civil matters, the Bundesgerichtshof, has denied a damages claim brought by a woman who received PIP breast implants against the certification body that was involved in the inspection of PIP production facilities TÜV Rheinland. This final judgment comes after the European Court of Justice of the EU had offered guidance to the Bundesgerichtshof as regards the scope of the inspection obligations TÜV Rheinland had under the applicable EU rules. For now,

New EU rules on medical devices

New EU rules to ensure safety of medical devices Brussels, 5 April 2017 The European Parliament and Council of Ministers adopted two new Regulations replacing the old Directive on Medical Devices (Dir. 93/42/EEG). The new rules cover medical devices and in vitro diagnostic medical devices, which include simple contact lenses and sticking plasters to sophisticated pacemakers and hip replacements. People rely on these devices every day and expect them to be safe and incorporate the latest progress in science

German follow up on CJEU ruling in PIP case

PIP Case on the Cause List on June 22nd The German Bundesgerichtshof announced on March 29th that the hearings in the case between Schmitt and TÜV Rheinland will be held on June 22nd. These hearing are planned after the Court of Justice of the European Union answered the questions raised by the German court through a preliminary reference procedure (Case C-219/15) in its decision of February 16th. Read the press release of the Bundesgerichtshof Read the decision

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