The European Council (EC) has just recommended extending the Medical Device Regulation (MDR 2017/745) transitional implementation deadline.
The proposal would see the May 26, 2024, deadline postponed until 2027 for higher-risk Class III and IIb devices, and May 2028 for lower-risk Class I and IIa devices. The aim is to ensure that patients can access safe, high-quality medical devices.
Reasons behind the proposed extension
The pandemic, raw material shortages due to the Ukraine conflict and larger workloads for Notified Bodies (NBs) have increased the risk of potential shortages while straining market readiness. Furthermore, national experts, industry groups and other stakeholders have voiced major concerns to the EC about products being taken off the market if nothing is done about the MDR transitional period deadline.
Supporting the transition
Geofrey De Visscher, Head of SGS NB 1639, said: “We welcome the proposed extension to the MDR implementation period. Our concerns, and those of our customers, have been heard.
“We are looking forward to the detailed measures to be taken and released as guidance. An extension will mean that we can better help customers transition their high-quality products to the MDR effectively, without risking a lack of availability in the market.
“It is likely that derogation and market surveillance audits will bridge the gap between old certificates expiring and the issuance of new ones.”
The EC will publish guidance outlining applicable conditions across all classes over the coming weeks.
Designation and why SGS?
In May 2021, MDR officially replaced the Medical Device Directive (MDD) to enhance safety for European patients through a more robust and transparent framework. This change also brings medical device regulations into line with technical advances, changes in medical science and progress in law-making.
Our Belgian NB was designated a European MDR NB by the European Commission and Belgian Competent Authority (FAMHP) under MDR (EU) 2017/745 in December 2021.
With existing approval under the UK Conformity Assessed (UKCA) scheme, we are one of the few companies that can provide certification services for medical devices across the whole of Europe.
More information on our medical devices services.
To start your MDR CE certification process, fill out our questionnaire.
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