Parliament and Commission disagree on pre-market authorisation
By Sophie Petitjean | Thursday 14 June 2012
The European Parliament has called for the review of Directive 93/42/EEC on medical devices to introduce more safety checks, better traceability and increased cooperation in order to avoid the placing on the market of defective equipment, such as the breast implants produced by the company PIP. Above all, a resolution, adopted in plenary on 14 June, calls for the European Commission to reconsider its opposition to a system of pre-market authorisation (PMA) for certain categories of medical device (IIb and III, the most dangerous).
However, during the debate preceding the vote, Health Commissioner John Dalli stuck to his guns: “The PIP scandal is a case of fraud: the problem is not authorisation, it is checks on the market, it is the implementation of legislation rather than the legislation itself [...] We need a flexible system which will allow for innovation that benefits patients. Europe’s advantage is that we have equipment three years before the United States. In this sense, I do not think we need a PMA system,”’ he said, while also confirming that he will present his proposal in September 2012.
STRICTER SAFETY TESTS
MEPs invited the Commission to develop an appropriate legal framework in order to guarantee the safety of mammary implants, and medical technology in general. They recommended the immediate revision of the directive on medical equipment in order to introduce the capacity to uncover and reduce the risk of fraud, particularly by clarifying measures on vigilance and monitoring of the market, as well as the tasks of notified bodies. More specifically, they called for the next review of legislation to focus on the following aspects: the need for a request for authorisation to place dangerous medical devices on the market, which would be similar to, or in line with, obligations for medical products; recourse to compulsory random inspections; the need for the increased traceability of medical implant devices; the need for increased coordination between member states on reporting of and warning against serious side-effects or damage caused by medical devices; the strengthening of checks by notified bodies, and the development of supplementary tests on samples of products which are already on the market. They also called for the creation of a passport for the ‘receiver’ of an implant, the creation of a single European database, and the establishment of an inventory of mammary implants in each member state.
“Europe’s advantage is that we have equipment three years before the United States,” said Dalli