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.
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.