Products without medical purpose within the scope of MDR

The new EU Medical Devices Regulation  2017/745 (MDR) officially entered into force on 25th May 2017 amending  the Directive 93/42/EEC and will be fully applicable after a transition  period of three years (2020). One of the most relevant changes  introduced by the new Regulation lies in the extension of its scope, now  including certain “products without an intended medical purpose”.

The extended scope of MDR

According to Article 1(2), the new Regulation 2017/745 shall apply to certain non-medical devices, as listed in MDR Annex XVI,  which present the same characteristics and risk profile as analogous  medical devices under the scope of the Regulation. Examples are the  following:
• Contact lenses
• Products intended to be introduced into the human body through surgically invasive means
• Facial dermal fillers
• Equipment for liposuction
• Lasers for skin resurfacing, tattoo or hair removal
• Equipment for electromagnetic brain stimulation

The new rules are going to cover certain, previously unregulated aesthetic products.

Where justified, in order to protect the  health and safety of users or other aspects of public health, the EU  Commission is entitled to amend the list of products of Annex XVI and  add new groups of products.

The MDR also envisages the introduction of Common Specifications (CS) meant as a set of technical and/or clinical requirements, to be  published by the Commission, which can replace harmonized standards for  risk management and clinical evaluation of Annex XVI products. According  to MDR Article 9, compliance with CS is compulsory for Annex XVI  products. Member States’ measures regarding the qualification of the  products covered by Annex XVI will however remain valid until the  application of the relevant common specifications for each group of  products.

Other products

According to MDR Article 2, the following products shall also fall under the definition of medical devices:
• Devices for the control or support of conception, regardless of whether intended to be used for a medical purpose
• Product specifically intended for cleaning, disinfection or sterilisation of devices

As a result of the aforementioned  changes, manufacturers are recommended to consider the impact of these  extended definitions on their products and assess the potential need for  new requirements to be met as soon as possible.

If you wish to learn more about the new medical devices regime introduced by New MDR, please do not hesitate to contact us. Obelis Expert Consultants, with nearly 30 years of experience with EU regulatory affairs, will gladly answer your questions and  assist you in ensuring compliance with new enhanced requirements.

Martina Quitadamo

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