knowledge 8 September 2017 |

Higher Risk Medical Devices - New Rules

EU regulations passed on 5 April 2017 will strengthen the regulation of medical devices, in particular higher risk medical devices (including defibrillators, pacemakers, prostheses and spinal needles, for example), and in vitro diagnostic medical devices. The regulations also impose greater responsibilities on manufacturers, distributors and importers. 

The new regulations clarify and reinforce the previous regulatory regime, including with regard to the classification of both medical devices and in vitro diagnostic medical devices and the conformity assessment procedures that must be satisfied before they can be lawfully placed on the market or put into service. In particular, higher risk medical devices and in vitro diagnostic medical devices will be subject to increased scrutiny, including review by independent panels of experts, appointed by the Commission, and testing by designated expert laboratories.

The new rules also require manufacturers to keep data to help with accountability, traceability, pre-emptive action and indeed reaction, in the case of serious incidents. For example, the new rules establish the following:

  1.   A “Unique Device Identification” database;
  2.   An electronic system for registration of economic operators;
  3.   A European database on medical devices (“Eudamed”);
  4.   An electronic system on notified bodies and certificates of conformity;
  5.   An electronic system on clinical investigations and performance studies;
  6.   An electronic system on vigilance and post-market surveillance; and
  7.   An electronic system on market surveillance.

The new regulations also provide for:

  • announced and, if necessary, unannounced inspections of the premises of economic operators, as well as suppliers and or subcontractors for all devices after they have been placed on the market;
  • stricter controls on notified bodies, which will have to employ medically skilled people;
  • an additional safety checking procedure for high risk devices which includes oversight by a special committee of experts; and
  • an “implant card” for patients, enhancing traceability.

Specific transitional provisions will apply until the regulations take full effect in 2020 (medical devices) and 2022 (in vitro diagnosticmedical devices). 

This document has been prepared by McCann FitzGerald LLP for general guidance only and should not be regarded as a substitute for professional advice. Such advice should always be taken before acting on any of the matters discussed.