New EU regulations for Medical Devices FOO
As the transition period commences for the new EU Regulation, Kathryn Moon, Life Science Specialist at Arthur J. Gallagher explores what effect the required changes will have on UK Medtech companies.
On 5th May 2017 the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) were published in the Official Journal of the European Union. The 25th May 2017 marked the start of a transition period, with a three-year transition period for the MDR and a five-year transition period for the IVDR.
The aim of the new regulations
- A consistently high level of health and safety protection for EU citizens using these products
- The free and fair trade of the products throughout the EU
- That EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.
What is changing?
The new regulations are far more extensive than the current directives, with the MDR increasing from 23 to 123 articles and the IVDR increasing from 24 to 113 articles.
Key changes include
- High–risk devices subjected to stricter control with a new pre-market scrutiny involving a pool of experts
- Tighter criteria for designation of Notified Bodies, the nationally-based organisations that put the system into effect, along with stronger oversight procedures
- A new risk classification system for in vitro diagnostic medical devices, that better reflects international guidance
- A comprehensive EU database of devices and a traceability system with Unique Device Identification
- Patient implant cards giving information about implanted devices
- Stronger rules on clinical evidence with EU-wide coordination of multi-centre investigations
- The introduction of joint and several liability for authorised representatives alongside the manufacturer of a device, applicable where the manufacturer is based outside the EU
- Tougher post-marketing surveillance rules for manufacturers
- Greater coordination between EU countries on vigilance and market surveillance.
Download the Legislation Bulletin July 2017