Medical technologies are tightly regulated in the European Union. Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device. There is EU sectoral legislation which specifically regulates the medical devices (MD) and In vitro diagnostic (IVD) medical devices sectors; these govern the safety and performance of devices across their lifetime.
During a set of transition periods manufacturers may choose to continue to comply with the applicable Directive or they may choose early compliance to the applicable Regulation:
During a 3 year transition period until 26 May 2020, medical devices can continue to be regulated under the Medical Devices Directive (MDD)and the Active Implantable Medical Devices Directive (AIMDD), or Manufacturers can choose to comply with the Medical Devices Regulation (MDR). From 26 May 2020, medical devices can only be placed on the market under the MDR (with certain exceptions given under the transitional provisions).
During a 5 year transition period until 26 May 2022, IVDs can continue to be regulated under the In Vitro Diagnostic Medical Devices Directive (IVDD) or manufacturers can choose to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). From 26 May 2022, IVDs can only be placed on the market under the IVDR (with certain exceptions given under the transitional provisions).
The transition periods are essential for ensuring a continued supply of CE-marked medical technologies to European and international markets. However most products may not be able to comply with the Regulations until late in the transition periods:
The European Commission needs to publish many implementing acts, which are laws needed to implement both Regulations. These laws will be gradually published during the transition periods.
Notified bodies may only be in place later during the transition periods. Notified bodies are the auditing bodies which certify products and quality management systems – without them most manufacturers cannot choose compliance to the new Regulation.
A new electronic platform called ‘Eudamed’ is only expected to be operational just before 2020. Compliance to both Regulations depends on Eudamed: ~ 75 articles and/or paragraphs in each Regulation are related to this new electronic and integrated platform.
Regardless if a product is CE-marked under the Directives or the Regulations, customers will continue to receive medical technologies with a high level of quality, safety and performance; the hallmark of the EU CE-marking system.
With the adoption of the European Parliament’s position in April 2014 and the Council’s General Approach of October 2015, Eucomed welcomes the fact that the file is moving forward and that ‘Trilogue’ negotiations can now begin with a view to adoption of a new Regulation in 2016.
Eucomed recognises the need to modernise and strengthen the current medical devices legislation in Europe, in particular, by strengthening the decentralised Notified Body system and increasing EU Member State co-ordination.