2 changes brought about by Regulation (EU) 2017/745

Regulation (EU) 2017/745 enters into force on 25/05/2017, and is fully applicable from 26/05/2021. This Regulation amends the various pre-existing rules governing the medical device system, taking into account the developments of the last twenty years, so as to ensure a comprehensive regulatory framework, adapted to the evolutions of the said medical devices.

The Regulation amends the following regulations

Directive 2001/83/EC (Community code relating to medicinal products for human use);

Regulation (EC) no. 178/2002 (food safety)

Regulation (EC) no. 1223/2009 (cosmetics)

and repealing

Directive 90/385/EEC (active implantable medical devices)

Directive 93/42/EEC (medical devices, including surgical masks).

The regulation has two precise and linked objectives: safety and innovation. Summarizing the changes, which are the most important?

The unambiguous identification of Medical Devices, i.e. the reconstruction of the itinerary of said devices along the supply/production chain, was a difficult, indeed impossible job. Regulation (EU) 2017/745 provided a strategy based on internationally recognized principles, with the application of a unique device identification system (UDI system), which gives the possibility to retrieve its complete itinerary.

Application of the new surveillance and supervision systems. The new Regulation reinforces the concepts of surveillance and vigilance and the responsibilities of manufacturers in this regard: the collection of data on their devices placed on the market and in service is no longer exclusively passive, i.e. based only on the management of complaints and accidents and/or adverse events occurred, but it becomes a proactive and continuous collection during the entire life cycle of the device, before and after placing on the market and putting into service. The data collected are used for continuous updating of the clinical evaluation and risk analysis to confirm compliance with the safety and performance requirements applicable to the device and to identify any critical issues that need to be analyzed as per the risk management plan.

These two changes harmonize with each other: the use of the UDI system on the traceability of Medical Devices would improve purchasing and waste disposal policies, as well as stock management by healthcare institutions and other economic operators and, if possible, be compatible with other authentication systems already present in these environments.

As far as the other objective of the Regulations is concerned, namely innovation, we must focus on the revision of the tender specifications, where the regulated part is adapted to the new rules and with the provision of stricter participation requirements for suppliers and the identification of precise responsibilities in case of accidents resulting from the use of the devices.

Particular attention is paid by the European Legislator towards small and medium-sized enterprises to encourage their participation in tenders for the supply of medical devices, this is in line with what was similarly expressed in the procurement directive 2016/24/EU where, in particular, it is asked to facilitate the participation of small and medium-sized enterprises (SMEs) in public procurement. Given the increased competition, we can expect new innovations.