European Parliament Issued a Resolution on PIP
The PIP resolution (Poly Implant Prothese, the French company that manufactured substandard breast implants) which was proposed by The Environment and Public Health (ENVI) Committee of the European Parliament was recently adopted with a unanimous vote.
The new measures adopted will improve the current regulatory framework for medical devices (in connection to the Medical Device Directive) and tighten the registration process for medical devices as well as insure greater provisions meant to protect patients, such as:
- The strengthening of the designation and control of Notified Bodies in the European Union;
- Better vigilance reporting and coordination of member states on incident assessments;
- Increased and unexpected controls of manufacturers by Notified Bodies based on experience from the post-market surveillance phase;
- Establishing tools to ensure the traceability of devices, particularly implants;
- Establishing registers for implants and having the registers interconnected.
In its proposal the ENVI committee recognizes the need for innovation in order to address current and future healthcare challenges and stresses the importance of appropriate clinical investigation of clinical data for all medical devices before they are marketed. Furthermore, for both implantable devices and medical devices in Class III, the clinical evaluation must be based on data obtained from clinical investigations unless it is justified to rely on existing clinical data. This is all applicable to medical devices that are to enter the European market and which in addition, need to comply with the CE marking requirements in order to have free access.
Moreover, companies producing medical devices that fall under one of the categories of the MDD 93/42/EEC are also obliged by the European law to designate a European Authorized Representative (EC REP) that will represent the manufacturer in front of the authorities and customers.