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MDR Annex XVI Common Specifications Adopted by European Regulators

New provisions cover products with no intended medical purpose

European Union flags flying in front of a building

October 21, 2022

The European Commission has adopted common specifications under Annex XVI of the Medical Devices Regulation (MDR) in a much-anticipated vote.

The Annex XVI common specifications cover products with no intended medical purpose that fall under the scope of the MDR. These products include contact lenses, electrical equipment for brain stimulation and liposuction equipment.

Still to come from European Commissioners are transitional provisions for Annex XVI products with Notified Body involvement and for which conformity assessments cannot be completed within six months. Transitional provisions are also expected for products such as breast implants falling under MDR Annex XVI for which Notified Bodies have issued CE certification according to Medical Devices Directive 93/42/EEC.

Manufacturers should note that additional provisions may be adopted pertaining to products and devices not currently commercialized in the EU or covered by MDR Annex XVI.

The Annex XVI common specifications will come into force 20 days following publication in the Official Journal of the European Union.


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