End in Sight for Discussions Over New EU Medical Device Regulations

Regulatory NewsRegulatory News | 28 October 2015 |  By 

New EU regulations for medical devices and in vitro diagnostics (IVDs) could be adopted as early as next year, a European Commission representative told attendees at RAPS' Regulatory Convergence on Tuesday.

The legislation would introduce stricter premarket rules for a range of medical devices, increase the powers and responsibilities of notified bodies and require new clinical evidence in some cases.

On 5 October 2015, the Ministers of the EU countries agreed on a general approach on the medical devices package after almost three years of discussions. The Commission said the agreement is a major step towards the adoption of new device regulations to help guarantee a higher level of health and safety protection for EU citizens.

The legislation follows multiple device scandals in the EU involving the dissemination of fraudulent breast implants and problems with some metal-on-metal hip replacements that raised new concerns about the safety of medical devices.

Discussions Underway

Speaking via video at the 2015 RAPS Regulatory Convergence, Erik Hansson, chair of the Commission's Medical Device Expert Group (MDEG) told attendees that trilogue discussions are underway between the Commission, European Parliament and the Council of the European Union.

In the EU, new legislation begins with the Commission drafting a proposal, which is amended and voted on by the Parliament before being sent to the Council. Once the Council adopts its general approach, the three bodies begin a trilogue discussion to work toward a final text.

Hansson said he hoped to see an agreement reached between the three governing bodies before the end of the year, but cautioned that a delay could push adoption of the legislation to late 2016.

While the legislation could be adopted within the next year, it would not take effect for three years from the date of adoption for medical devices and five years for IVDs.

Sticking Points

While the three proposals are mostly in line with one another, Hansson indicated that there is still some disagreement over several areas in the proposals.

According to Hansson, the Council, Parliament and Commission are still how a new 'scrutiny' mechanism for certain high risk devices will be implemented. In general, the scrutiny mechanism would allow a newly formed committee to monitor assessments being conducted by notified bodies to review both the manufacturer's application and the notified body's assessment.

Hansson also indicated that the Council would like to see the EUDAMED database verified before implementing the Commission's proposal for unique device identification (UDI).

Additionally, the Commission and Council are at odds over the reprocessing of single-use devices. Many medical devices, including certain syringes, scalpels and forceps are not intended to be reused by their original manufacturer. However, some of these devices can be safely sterilized and repackaged for subsequent use. The Commission is proposing that reprocessors be considered manufacturers and allowing individual member states to further restrict reprocessing under national law. On the other hand, the Council favors leaving single-use device reprocessing up to the member states to allow on a per country basis.


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