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In a bold move BSI has published its Notified Body capacity and an overview of the lead times for MDR & IVDR applications and conformity assessments.
“We are the first to publish this information for all our medical devices technology areas and related medical device types and codes. It demonstrates to both the medical device industry and the EU regulator our commitment to transparency”, says Dr Michael Weissig, Managing Director Medical Devices of BSI’s Regulatory Services division. “It also improves predictability of the MDR and IVDR certification process so that our customers know what to expect”, he adds.
These lead times can change rapidly, and they are influenced by several factors. Some of them are outside BSI’s control such as delays in agreed-upon submissions from manufacturers, change of plans, application withdrawals and last-minute cancellations.
Lead times serve as a reliable indicator of capacity in a very competitive medical device market as they are interrelated. Publishing these is even more relevant for manufacturers now that the 26th of May EU deadline for MDR applications is fast approaching.
“We commit to updating our capacity and lead times on a regular basis”, says Dr Haydar Jaafar, BSI’s Operations Delivery Director of the Medical Devices Leadership Team. “The capacity and lead times presented online should be considered as indicative at the time of publication.”
There are no agreed definitions or specified parameters at EU level for Notified Body capacity or lead times. The published information is based on BSI’s interpretation of these terms, considering its operational processes and client feedback.