News Category: Regulatory news
The European Commission is inviting stakeholders to give their feedback on a draft implementing regulation laying down the rules for the reclassification of certain active products without a medical purpose.
The consultation opened on 11 August 2022 and will run until 08 September 2022 (midnight Brussels time) and is available on the Commission’s webpage.
The Medical Devices Regulation (MDR) contains specific classification rules (9 and 10) for active devices with an intended medical purpose. These rules cannot be applied to Annex XVI active products such as:
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High intensity electromagnetic radiation emitting equipment used for hair removal,
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Equipment intended to reduce, remove, or destroy adipose tissue (liposuction).
The draft implementing regulation reclassifies these products to ensure that they are classified in line with their risks and are subject to the same pre and post-market requirements as comparable medical devices. These products will also require notified body involvement as part of their conformity assessment procedure.
This regulation will complement the requirements and timelines set out in the general common specifications for Annex XVI products which are also being finalised at an EU level.