European Parliament votes on Pre Market Authorization (PMA) elements in high risk device market access

Enews - 22 October 2013

Today, (22 October 2013) the European Parliament made a decision in the first Reading on the future of medical device regulations in Europe. The proposed amendments by the committee on Environment, Public health and Food Safety (ENVI)  and other working groups of the parliament created strong and fierce debates in preparation for today’s vote. A significant 1179 amendments were filed on the proposed Medical Device Regulation from the three groups on Employment and Social Affairs (EMPL), Internal market and Consumer Protection (IMCO) and ENVI working on the proposals, and another 532 on the In Vitro Diagnostics Regulation. The initial amendments were narrowed down to 30 MDD and 27 IVD consolidated and compromise amendments, that were mostly endorsed in the ENVI vote on September 25, including some of the remaining 1711 amendments. Subsequently further negotiations between political parties took place to file a further  30 consolidated amendments, that together with the compromises reached in the ENVI committee on 25 September, formed the basis of today’s plenary discussion and subsequent vote.

Today, new amendments were brought into the debate to refine the compromises from the earlier ENVI proposals. The amendments were proposed from various political groups, individually or combined. The topics still under debate included patient welfare and the prevention of fraudulent practice, the supervision on Special Notified Bodies, the scrutiny process of second guessing the Notified Bodies review, increased transparency, ethical approval on clinical studies and genetic testing.  Most of the debating surrounded the notorious compromise amendments 166, the extensive article where rapporteur Dagmar Roth Behrendt has tried to combine elements of her earlier Pre-Market Approval system for high risk devices under control of the European Medicines Agency (EMA), with the scrutiny procedure previously suggested in the original Commission proposal of 26 September 2012. Combining these elements would make for a highly bureaucratic system, where close to 600 clinicians would need to be employed by EMA to second guess the certification reviews made by as many clinical experts utilised by the so-called ‘Special Notified Bodies’.

The outcome of today’s first reading indicates that further compromises have been made and the conclusions reached in the parliamentary workgroups have been further refined to become more practical to implement. Many of last week’s amendments from Ms. McGuinness and Mr. Liese on the Special Notified Bodies, the Medical Device Advisory Committee and the Medical Device Coordination Group have been endorsed.  With that a lot of the proposed involvement of EMA has been removed from the ENVI proposal, reducing it to involvement in designation of Special Notified Bodies. The bar for these Special Notified Bodies has been set high on two key aspects. First of all in terms of qualifications, that are derived from TEAM-NB’s Code of Conduct with a twist to demand more industry experience for staff joining a Notified Body. Secondly  for investments in having in house clinical staff available in the Notified Body. As a result of the increased qualification requirements, and the prolonged review, that will include interactions with European expert groups during the dossier review, the time to market and the approval costs will significantly increase for high risk devices, implants and drug-delivery devices.

But the political process continues, the ball is now in the court of the Council of Ministers, who have to respond to the Commission’s proposal with the Parliament’s amendment.  If the proposal is not accepted, a counter proposal with commission comments will be returned to the Parliament for a continued reading. The negotiations are likely to   continue in various steps for another 16 months at most. However, the rapporteurs for MDD and IVD are pushing hard to get earlier resolution in the trialogue debates, in order to finish the legislative process before they break for parliamentary re-elections in spring 2014. In the debate in parliament, in the early hours of the day, Commissioner Mimiça identified his wish for early resolutions as well. Whether they will be successful in reaching their goal highly depends on the position of the Council of Ministers. As the Council Workgroups have not yet finalised their views, it could go either way: a delay to have a thorough analysis and well prepared next level legislation, or a political compromise to reach an agreement in a timely fashion. In that aspect today’s words from Mimiça were helpful: he indicated that the Lithuanian presidency of Europe has agreed to open the trialogue negotiations with Commission and Parliament before the end of the year. The chances of new regulations being endorsed before summer 2014 have significantly increased today.

Dr Gert Bos,Head of Regulatory & Clinical Affairs, BSI.