Brussels, 25/09/2013 (Agence Europe) - On 25 September, the environment and public health committee at the European Parliament adopted the report by Dagmar Roth-Behrendt (S&D, Germany) on medical devices and a report by Peter Liese (EPP, Germany) on in vitro medical devices. Following the PIP defective breast implant and the “metal-metal” prosthetic hip replacement scandals, the ENVI committee has given its opinion on the new European Commission proposed legislation to ensure that member states guarantee coherent application of European safety rules, help bolster the certification authorities and centralise authorisation procedures for certain devices. The committee did not retain the proposal for preliminary marketing authorisation, as proposed by Roth-Behrendt, which would have slowed down the process for marketing, due to the bureaucracy such a system would have provoked. MEPs, on the other hand, voted for better evaluation of these high-risk devices before they are marketed and a limited number of notified bodies that are allowed to process these categories. This will involve “special notified bodies” that are certified by the European Medicines Agency. In an effort to strengthen this mechanism, an experts' committee was also set up at the Commission, which will be in charge of providing a preliminary opinion on a case-by-case basis for dossiers that are still being examined by special notified bodies. The qualifications required for a notified body have therefore been strengthened and dual controls introduced. MEPs also opted for improved product traceability. The Greens proposed that when an alternative exists, the use of carcinogenic, mutagenic and toxic materials for reproduction or endocrine disruptors in medical devices are banned. The Greens regretted that an eight-year deadline had been introduced for this subject.
The vote on medical devices and their in vitro counterparts was planned for last week but this was postponed by a week due to pressure from the industry. MEPs are calling on all stakeholders to make a commitment to avoid any further delays occurring in the adoption process. Peter Liese declared that, “these rules directly affect the health of European citizens so we need to work swiftly to progress the legislation so citizens can benefit”. (IL/transl.fl)