The European Commission published a new Manual on borderline and classification for medical devices under Regulation 2017/745 on medical devices (“MDR”) and Regulation 2017/746 on in vitro diagnostic medical devices (“IVDR”) (the “Manual”). The Manual is intended to support manufacturers in determining whether their products fall within the scope of the Regulations and increase consistency across EU Member States when confronted with borderline products. The Manual reflects case-by-case agreements reached by the competent authorities of EU Member State members of the MDCG Borderline and Classification Working Group (“BCWG”) through the Helsinki procedure in relation to the qualification and classification of products in accordance with the new Regulations.

The new Manual replaces the previous Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices which provided guidance in accordance with Directives 93/42 on medical devices, 98/79 on IVDs and 90/385 on active implantable medical devices. The previous manual will remain accessible as long as devices that have been CE marked in accordance with the Directives are available on the EU market. However, it will no longer be updated.

The most noteworthy updates of the new Manual include:

  • Additional examples of products on the borderline between medical devices and medicinal products, including Advanced Therapy Medicinal Products (“ATMPs”); medical devices and IVDs; medical devices and biocides; and medical devices and Personal Protective Equipment (“PPE”),
  • Considerations for COVID-19 related products (e.g., plexiglas box for caregiver protection),
  • Classifications for a rescue bag for patient transport and an implantable dermal filler in accordance with the MDR.

The Manual may serve as guidance for qualification and classification purposes but is not legally binding. This means that while it is recommended that manufacturers of medical devices and IVDs take the Manual into consideration, they are not required to comply with the views expressed therein. The Manual should also be read in conjunction with other MDCG documents providing guidance on borderline cases and the classification of medical devices and IVDs.

The Manual will be updated as more agreements in relation to borderline products are reached by the BCWG. 

This blog was authored by Jessica Koffel, Alexander Wenzel and Anastasia Vernikou.

Posted by Cooley