Two new Regulations on medical devices, which are meant to ensure better protection of public health and patient safety, came into force on 5 April 2017.
The new Regulations on medical and in-vitro diagnostic medical devices were proposed by the Commission in 2012 and adopted by wide majority votes in the European Parliament.
The new rules are meant to improve market surveillance and traceability. The rules are supposed to also provide more transparency and legal certainty for producers, manufacturers and importers and help strengthen international competitiveness and innovation in this strategic sector. With the legislative procedure, having finished, the new rules will start to apply 3 years after publication of the Regulation for medical devices and 5 years after publication or in vitro diagnostic medical devices.
There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market.
The existing regulatory framework dates back to the 1990s and consists of three Directives. However, problems with divergences in the interpretation and application of the rules, technological progress highlighted the need for revision of current legislation. The Commission is also currently working on more structural and horizontal solutions for better market surveillance within the broader frame of a goods package reform.
Following the 2010 Poly Implant Prothèse (PIP) breast implants scandal, the Commission presented a package consisting of two legislative proposals on Medical Devices and In Vitro Diagnostic medical devices. Since then it has been a long running process until the formal adoption of the compromise text by the co-legislators in March and April 2017. The adopted texts tend to reinforce the obligations for manufacturers.
On paper, there is clearly progress made towards better patient safety. However, whether this can be implemented and actually 'put into practice' in the future is yet to be seen. One of the challenges is that many of the rules in the new regulation are generalised and must be given specific form through legislative acts.