MEDICAL AND IN-VITRO MEDICAL DEVICES

16/07/2016 1687 Views
MEDICAL AND IN-VITRO MEDICAL DEVICES

On 25th May 2016, the European Parliament and the Council reached an agreement on the two European Commission proposals on medical devices and in-vitro medical devices, which were first presented in 2012.

The basis of the EU legal framework for medical devices and in-vitro medical devices was laid in the 1990s. It has since been agreed that the legal framework has a sound basis, but there are several aspects that need to be improved. Moreover, medical devices and in-vitro medical devices have become increasingly more sophisticated and innovative, leading to a need to modernise the legislation.  As such, the revision aims to reduce the discrepancies in Member States’ interpretation and application of the rules, as well as the regulatory flaws and gaps with regard to certain devices. The overall objective is to guarantee a high level of protection of human health and safety, ensure a smooth functioning of the internal market and provide a regulatory framework that supports innovation and competitiveness in the European medical device industry.

After the initial presentation of the two European Commission proposals on 26 September 2012, the European Parliament and the Council have developed their own positions and worked in trilogues to reach a common agreement. The tenth trilogue proved to be successful and has now paved the way for a vote in the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee, which has been scheduled for 15th June 2016. Rapporteurs Glenis Willmott (S&D, UK) and Peter Liese (EPP, Germany) will continue leading the work on these dossiers.

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