Years of legislative process on the Community level and of discussions among legal and industry experts reach their culmination
Two new European regulations were published on 5 May 2017 in the Official Journal of the European Union, one concerning medical devices as such, and the other in vitro diagnostic devices specifically. After more than five years, this marks the culmination of a legislative process which had itself been preceded by several years of discussions by the professional community.
The primary objective of the new regulation is to deliver improvements in the areas of safety and traceability of medical devices. It anticipates the introduction of more stringent audits of notified parties and higher demands with respect to the technical documentation and with respect to clinical evaluations. A Unique Device Identification (UDI) system will be introduced, as well as a European Database of Medical Devices (EUDAMED) in which any medical device introduced to the market can be traced (using the aforementioned UDI). The reporting of serious incidents and corrective actions will be centralized on an EU portal.
Before bringing high-risk devices to market, consultations must take place on the level of the EU, and additional review procedures are being put into place for them.
The broader administrative demands may be expected to slow down the introduction of new products to the market. However, one has to keep in mind that, whereas more or less all medicinal products have to be registered within an approval procedure before they can be brought to market, safety assurance for medical devices was previously based on a self-assessment by the producer. Making the rules stricter was in this sense driven by the aim to fix the system for product safety and traceability. The extent to which this will actually benefit the final consumer – the patient – depends on how the regulations will hold up to applied practice.
The transitional period for implementation is three years for medical devices, and five years for in vitro diagnostic medical devices.
The new regulations supersede the previous directive on medical devices; given their direct effect, national legislation will have to be adjusted during a transitional period to conform to them, and the same holds true for the internal procedures and guidelines of anyone involved in the chain of manufacturing, distributing, and consuming medical devices.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC;
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU