by Lu Rahman, Medical Plastics News – May 5, 2017
The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR).
The next step is a transition period of three years for medical devices and five years for in-vitro devices (IVD)s meaning that the new rules will fully apply at the end of May 2020 for medical devices and at the end of May 2022 for IVDs.
“The medical technology industry welcomes the fact that the transition and implementation period has finally come” said Serge Bernasconi, CEO of MedTech Europe. “Now we open a new chapter – the industry is ready to collaborate with all actors to ensure a timely and smooth transition to the new regulations.”, he added.
Going forward, implementation of the regulations is a top priority for the industry and MedTech Europe. With the publication of the regulations, a new and intensive phase of work begins for regulators and stakeholders. Many pieces of secondary legislation and guidelines will need to be developed in order to be able to implement the regulations on time.
It is important that notified bodies are designated early in the transition period and have the capacity to manage the assessment of over 500,000 medical technologies to the updated requirements within the set timeframe.
