Annex XVI

Compliance with MDR and Common Specifications (CSs)

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Medical Device Regulation – Annex XVI

Annex XVI of the European Union’s (EU) Medical Device Regulation (MDR) covers previously unregulated products and introduces new manufacturing and surveillance requirements.

For the first time, manufacturers of aesthetic devices, which are similar to medical devices in terms of function and risk profile, will be required to demonstrate compliance with common specifications (CSs). These define how devices should be assessed to demonstrate safety and performance and they are expected to be released in the first quarter of 2022.

Once the CSs are officially published, manufacturers will then have only six months to comply - bringing into sharp focus the importance of starting compliance preparation now. To prepare relevant technical documentation, it is essential to have a detailed insight into the MDR’s General Safety and Performance Requirements, equivalence approach, clinical data and post-market requirements.

By date of Application certain groups of products without the intended medical purpose, needs to be in line with all other medical devices and will be required to comply with the obligations set out in the MDR to be brought into the EU market.

How can TÜV SÜD help you?

TÜV SÜD is one of the largest EU Notified Body authorised to provide certification services under the MDR. We are recognised by global regulatory authorities for our extensive experience with all types of medical devices and offer manufacturers of aesthetic devices a complete range of testing, certification and auditing services.

Our team of experts includes noted scientists and physicians that are recognised as global authorities in the aesthetics field. Our vast clinical, technical and regulatory expertise will ensure you fully understand the MDR requirements in order to be prepared once Annex XVI CSs are released.