Czech Business Today

European Economic and Social Committee adopted at its plenary session the opinion on the Commission’s package of proposals to improve control over the manufacturing and marketing of medical devices and diagnostic medical devices in vitro. 

The proposals are a response to particular hardships caused to tens of thousands of women due to the use of improper silicone breast implants. This raised a legitimate public clamour for stricter requirements for the approval of medical devices in Europe. The EESC welcomed the proposal to establish effective rules to strengthen the approval procedures prior to marketing and for surveillance after launch. We supported the proposed legal form of “regulation” rather than “directive” to prevent a different interpretation of the rules by individual Member States, to bring to European patients greater equality as well as a level playing field to suppliers. European approval system for medical devices is decentralized in contrast to the U.S. system. 

Some representatives of various civil society organizations are calling for the introduction of a similar centralized system in the EU. The comparison of the two systems, however, shows the advantages of the European solution. The average time of approval of new medical devices in the U.S. is about 43 months longer. Experience has shown that it does not guarantee more stringent requirements for these products, because the U.S. Bureau decided only on 22 cases differently from European authorized bodies during last few years. Medical device industry is one of the few areas where the EU has a technological lead over the U.S. thanks to the flexible authorization system. Many American manufacturers, therefore, transferred its production capacity to the EU. A major contribution of the system is a faster access to the latest medical technologies. The introduction of a centralized system would cause delays in access to new therapeutic methods, which would harm patients, without thereby increasing their protection. 

EESC supports the highest standards approval process for the high-risk medical devices and diagnostic medical devices in vitro before launching them in the market. Their safety must be demonstrated by reliable results of appropriate clinical trials and investigations. Repetition of fraudulent replacement of material for breast implants, which was a criminal act, cannot be avoided by the centralization of the certification process but only through rigorous inspections of the manufacturing process by the supervisory authorities. 

Ivan Voleš
Member of the EESC – Group I, co-rapporteur on SMA II