A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence.


Liability Spotlight now on the Notified Bodies

Background and Context

The so-called PIP-Breast-implant scandal now reaches the Court of Justice of the European Union (CJEU). As last week a German court referred a liability case to the CJEU, it is now upon the CJEU to provide further clarity on the responsibilities and liability scheme for medical devices in the EU. The key questions relate to the responsibility of the Notified Bodies which are in charge of granting the CE mark which again is required to place medical devices on the EU market. The CJEU’s answer will have an impact on the work of Notified Bodies and will be relevant for the liability of medical device manufacturers in the EU.

In the current case, the plaintiff has sued the German Notified Body TÜV Rheinland for damages as she had been implanted a PIP breast implant. PIP stands for the company name Poly Implant Prothèse which, for years, was illegally selling breast implants containing industrial silicone instead of the medical silicone for which they had received the CE mark. The founder of PIP and several former executives and managers were convicted of fraud and sentenced to jail by a court in France.
Continue Reading European Court to Clarify Responsibilities and Liability for Medical Devices

On 4 February 2015, the German Ministry of Justice published a new draft law specifically aimed to combat corruption in the healthcare sector. Key element of the draft legislation will be a newly defined criminal offence that will be inserted as a new Section 299a of the German Criminal Code (StGB). This new criminal offence sanctions active and passive bribery of a wide range of healthcare professionals – not only of medical doctors.

The envisioned new § 299a StGB would significantly sharpen the German anti-corruption laws as far as interactions between life sciences companies with medical doctors and other healthcare professionals are concerned. The criminal culpability would apply to both the healthcare professional that accepts a bribe and the company representative that pays a bribe.
Continue Reading Germany Headed to Stricter Criminal Laws Against “Corruption In The Healthcare Sector”