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No sticking plaster: major EU medical devices reform cleared today

Press Release

Wednesday 5 Apr 2017

Today, after years of painstaking negotiations and two rounds of readings between the European Parliament and the Council of EU Member State ministers, Parliament gave its final approval to a long awaited reform of the EU rules governing medical devices.

Scandals with faulty breast and hip replacement implants in recent years had laid bare the inadequacies of a regulatory regime which dated back to over two decades.

All such kinds of implants will be identifiable by a unique number – which is also given to patients in a personal implant card – as part of a consolidated database, and subjected to thorough checks before and after they are put to use.

Traceability is essential to ensure that a picture of any complications can be drawn quickly, with mandatory reporting to the competent authorities, and acted upon, by restricting the device if necessary.

The national bodies in charge of compliance themselves subjected to reviews and EU-level coordination to keep up to the best international standards and practice.

National governments can demand liability insurance from manufacturers, and there are mandatory financial capacity requirements for manufacturers, to ensure patients can be compensated if necessary.

Wrong diagnoses, false positives and negatives can have very serious consequences. Diagnostic devices such as blood tests were also subjected to revamped rules.

They were likewise subjected to more stringent testing, surveillance and liability requirements.

Unannounced inspections of the production sites are also mandatory for complex, riskier devices.

In Parliament, work on this reform was led by my political grouping, the Socialists and Democrats, in the Public Health committee, where already I sat in the last term.

It was back in 2012 that the EU Parliament reached its own position but national governments spent years grappling with their differences over this file before coming to the table with a common position to negotiate with Parliament in 2015.


For more information:

Medical Devices: more safety, more traceability