What is the Annex XVI about?

The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD and entered into force on 25 May 2017 with 26 May 2021 as date of application.

Certain products with only aesthetic or non-medical purpose that exhibit similarities to medical devices in terms of functionality and risk profile, are now covered by the EU MDR.

Manufacturers of these products manufactured in European Union incl. Northern Ireland will have to comply with the relevant requirements laid out in the MDR for general medical devices to ensure user safety, including compliance with the relevant Common Specifications ((EU) 2022/2346).

The Annex XVI of the MDR EU 2017/745 lists products (6 categories) without an intended medical purpose that now fall under the MDR:

  1. Contact lenses or other items intended to be introduced into/onto the eye.
  2. Introduced into the body for the purpose of modifying the anatomy or fixation of body parts.
  3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
  4. Equipment intended to be used to reduce, remove or destroy adipose tissue.
  5. Lasers and IPL equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
  6. Equipment intended for brain stimulation.

How We Can Help

We specialize in providing regulatory compliance services for medical device manufacturers and distributors. Our team of experts is well-versed in the requirements of Annex XVI and can assist you in navigating the regulatory landscape to ensure your products meet the highest standards of safety and quality.

From conducting conformity assessments and technical documentation reviews to providing guidance on clinical evaluations and post-market surveillance, we offer comprehensive support throughout the regulatory process. With our knowledge and experience, you can trust BSI to help you achieve compliance and bring safe and effective medical devices to market.

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