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EU Medical Devices Legislation – An Update

Reform of the Medical Device regulatory framework, where are we?

Published for the first time in 2012, the EU Commission’s proposal is stuck as EU Member States cannot agree on key point of the file.

The major disagreement is on the Article 44 of the proposal and the pre-market approval of high-risk devices. The Article lays down provisions on Conformity Assessment of medical devices thus: “… in class III requiring explicit prior approval of their design and manufacture before they can be placed on the market”. Contrary to the current situation, this new requirement would mean that all Class III devices will have to be centrally assessed to certain clinical & safety standards.

On the one hand, several Member States believe that duplicating the assessment for Class III devices is unnecessary and not practical, due to the difference between the large amount of Class III devices to be assessed and the current capacity to assess them centrally at EU level. Additionally, they fear that such duplication may delay the adoption of innovative technologies access in the EU market. Nevertheless, other Member States see this new scrutiny system as essential and operationally feasible.

What do we expect now?

The European Parliament adopted its position quite quickly in 2013, and this was followed by a vote in plenary in April 2014.

However, due to the new Members of the European Parliament, which were elected last May, and the change of the Rapporteur dealing with the Commission’s proposal in the Parliament, it is difficult to anticipate how the “new” Parliament will react regarding the Council’s position.

The Commission’s proposal is drowning in controversy and there is still a lot to agree. We will have to wait until the three EU Institutions discuss and arrive to a common agreement, which will be, for sure, an interesting debate to follow.

Obelis can provide manufacturers with a wide range of services, such as product safety consultancy and regulatory advice, aimed at ensuring that their devices are aligned with the latest regulatory and scientific evolutions.

Please contact us for more information.