The publication by the European Commission of two proposals for the revision of the EU regulatory framework for medical devices in September has initiated the legislative process which will ultimately lead to the adoption of the final EU Regulations on medical devices. The proposals have been transmitted to the European Parliament and Council for their consideration.
At the European Parliament, the proposals have been assigned to the ENVI parliamentary Committee, responsible for environmental and public health matters. Two German Members of the European Parliament have been appointed as “rapporteurs”, i.e., leaders of the parliamentary process: Mrs. Dagmar ROTH-BEHRENDT from the Socialists and Democrats’ group for the Regulation on medical devices and Mr. Peter LIESE from the Christian-democrats for the Regulation on IVDs. Once adopted within the ENVI Committee, the reports will be sent to the consideration of the entire European Parliament, which will adopt its position on the legislation. While the parliamentary work should begin early next year, the European Parliament’s plenary vote is currently expected for September 2013.
Once adopted, the Parliament’s position will then formally be transmitted to the Council, representing the EU Member States. In particular, the so-called EPSCO Council (gathering the Employment, Social Policy, Health and Consumer Affairs Ministers) will define the Member States’ position. In practice, however, technical experts from Member States have already started to examine the proposals. If the Parliament and the Council are in agreement at this stage of the procedure, the act will be adopted at a so-called first reading.
If the new Regulations are not adopted at the first reading, the Council’s position will go back to Parliament for the “second reading.” The process described above is essentially repeated all over again, with, however, certain limits imposed on the European Parliament as to the substance on amendments proposed on the Council position. If no agreement is reached during the second reading, a conciliation committee is formed comprising members of the Parliament and the Council to try to agree on a joint text. If they do reach an agreement, the joint text must then go to the Parliament and Council for final approval.
Importantly, there seems to be a consensus in the EU on the need for new regulations on medical devices, in particular because of the recent breast implants and metal-on-metal hip joint replacements developments. It is thus unlikely that the European Parliament and the Council would ultimately fail to agree on new Regulations. Moreover, the next elections of the European Parliament will take place in June 2014 and it is likely that EU politicians will want to show concrete results by then. While this is of course difficult to estimate, an adoption of the final Regulations in the course of the first half of 2014 is probable. It will be critical for companies that have products on the EU market to monitor the legislative process. Given that this process will unfold over at least one year, there will be numerous opportunities for companies to make their voices heard on aspects of the new regulatory system.