MDR: a Notified Body perspective and beyond.

Notified Bodies are a key player in the implementation of MDR. Acting as the main agents of Europe and the local Competent Authorities, we are at the forefront of the changes, in our case the new MDR and Brexit, that need to allow the industry to keep and bring Medical Devices to the European market.
This is a daunting task which needs to be finalized by May 2024 with the majority of the work still laying ahead of us.

Therefore, the presentation will focus on where we are, what the foreseeable bottlenecks are and what the important considerations are for organizations needing CE marking by a Notified Body.

A presentation by Geofrey De Visscher, Head of Notified Body 1639 at SGS Belgium NV.

He is driven by Problems and ideas and finds the new technologies based on AI in medtech and in vitro diagnostics the ones who will have the greatest potential, but also the greatest challenge. We see more and more of these products on the market, however they do not fit the standard idea of a product which is from a regulatory point probably the most interesting question since ATMP’s were developed.

About Geofrey De Visscher
Geofrey De Visscher is a leader and product innovator with about 20 years’ experience in management of creative development groups for medical device, diagnostics, biotech and pharma. Having started academia (VUB, University Maastricht and, KULeuven), he transited into industry by founding his medical device – biotech company (Anethon) based on his own invention. Today, Geofrey is Head of Notified Body 1639 of at SGS Belgium NV, leading the transition of a business affected by Brexit and the change in regulation.

About SGS Belgium NV
We are SGS – the world’s leading testing, inspection and certification company.

We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.

Wherever you are, whatever your industry, our experts worldwide provide specialized solutions to make your business faster, simpler and more efficient.

Geofrey De Visscher is speaker at the 2022 edition of the Health Tech Event.

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