The Medical Devices Regulation (MDR) and the In-vitro Diagnostics Regulation (IVDR) of the European Commission (EC) have been the most important developments for medical device manufacturers interested in entering the European market. The EU (European Union) regulators will be able to exercise the necessary control and supervision over medical devices that enter the market as a result of these regulations. The MDR and IVDR work together to ensure that goods are reliable, legal, and freely and reasonably traded throughout the region.
The rules, which took effect on May 25, 2017, are intended to replace the current Medical Devices Directives (MDD). Both the MDR and the IVDR are set to take effect in May 2020, respectively. Companies must comply with these regulations, failure to do so will result in their operating licence being revoked.
The European Commission has taken major measures to assist businesses with the MDR/IVDR transition, including:
Notified Bodies (NBs) Designation- The European Commission has designated two Notified Bodies (NBs) for MDR, BSI UK and TÜV SÜD, but none for IVDR. The European Commission is scheduled to nominate 20 more NBs.
Implementing Acts’ Publishing – The EC has also published two of the MDR/IVDR Implementing Acts, which were adopted on the list of codes for designating NBs under MDR/IVDR. In addition, in conjunction with MDR, the EC published a draught of Implementing Acts on common specifications for the reprocessing of single-use medical devices.
While several companies are working diligently to prepare for the transition, the United States (US) has expressed concerns about the regulations’ effective implementation and has requested a three-year extension. The following are some of the United States’ concerns:
There is a shortage of notified bodies (NBs) assigned to facilitate MDR/IVDR transitions in a timely manner.
There are no Implementing Acts in place to ensure that emerging product requirements are followed.
Aside from the above issues, the United States has expressed concern to the World Trade Organization’s committee on technological barriers to trade regarding their continued access to the EU’s medical device market.
Reasons behind the United States’ Request for a Delay in Implementation:
The transitional relief that the MDR/IVDR provisions aim to provide is inadequate
The system specifications required for MDR enforcement cannot be achieved before the deadline
The US also believes that, given existing quality specifications and EU deadlines, US exporters will be unable to adjust to the new requirements. As a result, the US is urging the EU to:
To keep legacy products that is currently considered “safe” on the market until 2024.
To place a higher priority on medical devices that needs new certification than those that need recertification.
The transformation can seem complicated and time-consuming to most medical device manufacturers. Compliance can only be achieved by a standardized and well-managed strategy for the next three years. Throughout the operation, stay updated and compliant. Seek advice from a professional.
CATEGORY: Medical Devices, Regulatory Affairs
Keywords: Medical Devices, Medical Devices Regulation (MDR), In-vitro Diagnostics Regulation (IVDR), European Commission (EC), EU (European Union), Medical Devices Directives (MDD), Notified Bodies (NBs).
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