Changes to Medical Devices Regulations

In April 2017 the new EU Medical Devices Regulation and the EU in vitro Diagnostics Regulation (together, the ‘Regulations’) were adopted by the European Parliament. The regulations aim to ensure the smooth functioning of the medical devices internal market, ensuring a high level of protection of health for patients and users, having regard for the businesses active in the sector.

The regulatory system needed to evolve to reflect new methods and technology that have been and continue to be introduced across the sector, and because technological advancements have increased the complexity of medical devices. The three main areas of change are:
1. the broadening of the definition of medical devices so a wider set of products will fall within the scope of the regulations, including software and products without an intended medical purpose such as contact lenses, equipment for liposuction and lasers for skin treatments; the reclassification of certain devices into higher-risk categories so they require approval from notified bodies who themselves will be subject to heightened requirements, including a redesignation process and consistent reassessment to check that the notified bodies are effectively monitoring and enforcing requirements.
2. the enhancement of transparency, accountability and vigilance of all suppliers in the medical devices sector, through the use of a unique device identifier (UDI) for each device which will be logged on the European database (EUDAMED). This live picture of devices progressing through the supply chain will help to detect counterfeit devices and enable effective product recall. Enhanced market and post-market surveillance will improve the safety of the devices.
3. the assurance of accountability for all participants in the supply chain so that they all have potential responsibility for any defect in devices, not just the manufacturers.

The final implementation dates are 26th May 2020 for medical devices and 26th May 2022 for in vitro devices.