Agreement reached on new European medical devices legislation

New provisions for medical devices and in vitro diagnostics have been decided at the informal trialogue on 25 May 2016. The regulations provide for a tightening of the rules for placing medical devices on the market and for more stringent monitoring after their market launch.
Gesundheit / health
©Alexander Raths - fotolia.com

The European legislation for medical devices has been undergoing revision since 2008. On 26 September 2012, the European Commission (EC) published its proposals for a regulation on medical devices (MDR) and for a regulation on in vitro diagnostics (IVDR). At the start of November 2015, the interinstitutional negotiations began, known as the informal trialogue. This is not provided for under the Rules of Procedure of the European Parliament (EP) and serves to accelerate the legislative procedure. The trialogue was ended on 25 May 2016 with a compromise between the EC, EP and European Council (Council).

The aim is to ensure the smooth functioning of the Single Market of medical devices and to guarantee and increase the protection of patients and users in Europe. In order to increase the safety and quality of medical devices, the new MDR/IVDR has therefore placed numerous new and tighter requirements upon manufacturers, notified bodies and a diverse range of other players in the healthcare system.

Implementation will be a challenge

There are numerous challenges for the medical device sector attached to these two regulations. National laws and specifications will have to be fundamentally reviewed by the EU member states, and the effort involved in designating and monitoring the conformity assessment bodies and the market surveillance will sharply increase.

The new regulations include that manufacturers must fulfil much tighter requirements, for example, in regard to clinical evaluations, documentation and aftermarket control. The requirements upon the notified bodies have also been raised. In addition, they will be monitored more stringently in the future. At the same time though, their role in the system will be reinforced by additional monitoring and inspection tasks.

The mass of new requirements and numerous unanswered questions - or specifications which are still to be decided - within a short timeframe for implementation could overburden the system, at least in some aspects. The effects – particularly upon safety, supply and innovations – remain unclear.

Next steps

In September 2016, the results of the trialogue’s negotiations are expected to be adopted by the Council. The vote in the EP will take place in autumn 2016 in the form of the second reading. The two regulations are likely to enter into force in late 2016 / early 2017 upon their publication in the Official Journal of the European Union. The MDR would then likely become mandatory at the end of 2019 / start of 2020 – with a three-year transitional period. The IVDR needs to be implemented on a mandatory basis at a later time – likely late 2020 / early 2021 – with a five-year transitional period. There are also, in part, longer and shorter transitional periods; the new designation procedures, for example, will have a transitional period of six months.


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