Common Specifications for Borderline Medical Devices in EU
On December 01, 2022, the European Commission published Document C(2022)8626 - laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
Several general specifications have been listed for medical devices of different categories and risk classes. This one, specifically addresses to the groups of products without an intended medical purpose as listed in annex XVI under the Medical Device Regulations [EU MDR 2017/745].
What do MedTech or Borderline Medical Device Manufacturers in/for the European Market need to know?
As mentioned previously, product groups listed under EU MDR Annex XVI are those products where the manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices in terms of functioning and risk profile.
Manufacturers need to focus on
- - Application of an effective risk management plan as per the general safety and performance requirements [GSPR] listed under Annex I [click here].
- - Manufacturers may need to perform a clinical evaluation to prove the safety of their innovation.
- - With the application of Common Specifications [click here], MDR – Medical Device Regulation will also APPLY to those groups of products without an intended Medical purpose [Annex XVI of EU MDR].
- - Sections 1, 2 to 5, 8 and 9 of the EU MDR lay down demonstration of conformity and risk management requirements for ‘Products without intended Medical Purpose.’ Manufacturers need to incorporate these risk management and conformity requirements.
- - In places where the manufacturer of such product has proven the conformity with common specifications, the Commission can presume compliance with risk management requirements.
- - While the common specifications are applicable to all the products included in the annex XVI of the EU MDR – these specifications are NOT NEEDED for products for which there is NO INFORMATION of them being available on the EU market.
- Eg - contact lenses containing tools, such as antenna or microchip, contact lenses which are active devices;
- - active implantable products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixing a part of the body;
- - active devices intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction;
- - active implantable equipment intended to be used to reduce, remove or destroy adipose tissue. In addition, for some products the information available is not sufficient to allow the Commission to draw up common specifications. That is for example the case for some other items intended to be introduced into or onto the eye.
Products like Sunbeds and other equipment that use infrared optical radiation to warm body or parts of the body do not require compliance to the EU Medical Device Regulation. The group of products listed in point 6 of Annex XVI to Regulation (EU) 2017/745 is intended for brain stimulation where only electrical currents or magnetic or electromagnetic fields penetrate the cranium. Invasive devices intended for brain stimulation, such as electrodes or sensors that are partially or totally introduced into the human body, should not be covered by this Regulation.
Through this document and publication, the Commission has asked for active awareness and creation of harmonised risk management standards for all the products with or without intended medical purpose.
More details can be found on - https://eur-lex.europa.eu/resource.html?uri=cellar:c8ce5c99-716b-11ed-9887-01aa75ed71a1.0005.02/DOC_1&format=PDF
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