Big news in the medical devices sector: the new Regulation 2017/745 on Medical Devices. Today, 5 May, the European Parliament and the Council of Europe have published the two documents on medical devices that we have been awaiting. Both publications are official and have the backing of all the European authorities. From now on, these two texts will form the regulatory framework for medical devices and in vitro diagnostic (IVD) devices in the European Union:
- on Regulation 2017/745 on Medical Devices (175 pages, 123 articles, 10 chapters and 16 appendices)
- on Regulation 2017/746 on In Vitro Diagnostic Medical Devices -IVDs (157 pages, 113 articles, 10 chapters and 15 appendices).
Background to the publication
On 17 June 2016, the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), which reports to the European Commission, approved the new regulations. Following months of review, on 7 March 2017, the Council of Europe also endorsed the texts. Finally, the European Parliament approved them on 5 April.
When will the new Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic medical devices come into force?
Now that the new European Regulations have been published, they will enter into force in 20 days. However, Regulation 2017/745 on medical devices will become mandatory three years after its entry into force. That is, on 26 May 2020. And Regulation 2017/746 on in vitro diagnostic medical devices will apply five years after it comes into force. That is, on 26 May 2022.
Finally, we would like to remind you that the Pharmaceutical Technical Committee is a leading source of information on the regulation of medical devices and cosmetics. For further information on these new regulations, please refer to the section on News about medical devices on the GTF M. Camps blog