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.
Furthermore, many clarifications are urgently needed, eg on clinical requirements, to enable the industry to apply the new rules as quickly as possible and with minimum disruption for patients, health care professionals and health systems.
IVDs
For the in-vitro diagnostic sector, this new regulation represents a fundamental legislative change with new or major shifts in areas such as the classification system, performance evaluation and clinical evidence, and conformity assessment of IVDs.
Medical device sector
For the medical device sector, the new regulation brings more detailed clinical evaluation requirements, a new “scrutiny” process and an increased Commission and Authority control and monitoring of a strengthened notified body system.
MedTech Europe says it welcomes the European Commission and Competent Authorities’ initiative to consult stakeholders in developing an official implementation roadmap. It is crucial that within this roadmap the specificities and differing nature of in-vitro diagnostics continue to be recognised. A clear roadmap will ensure that all players – regulators, notified bodies and economic operators – can successfully transition to the new Regulations.
“MedTech Europe is fully aware that within such large and complex texts there are still a lot of questions waiting to be answered. We will continue our work with members, regulators and external stakeholders to ensure effective implementation of these new rules” Bernasconi added.