The published version 1 of the Manual on borderline and classification for Medical Devices under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices guideline is supportive in determining whether a borderline product falls under the definition of a medical device and under what classification rules.

The document, which mentions examples and case studies, aims to clarify the rules of placing a product on the market when such product is not immediately defined as a medical device (or IVD) because considered borderline, as its definition may fall into other categories such as IVD (or medical device), drugs, cosmetics, biocides, food, personal protective equipment, consumer products or other categories.

Once identified as a medical device or IVD it is then necessary to identify the applicable hazard class i.e. I, IIa, IIb, III (for Medical Devices) or A, B, C and D in case of IVD devices. The classification rules for Medical Devices are governed by Article 51 Classification of Devices and Annex VIII of MDR (EU) 2017/745. For IVDR (EU) 2017/746, however, the corresponding references are Article 47 and Annex VIII. There are some classification cases in the guideline for which the Competent Authorities of Member States find difficulties in uniformly applying the classification rules.

The handbook, drawn up by the Member State members of the Borderline and Classification Working Group, a subgroup of the Medical Device Coordination Group, is an important reference point for Manufacturers when assessing product conformity even though it should be applied on a case-by-case basis according to Union regulations, without prejudice to the final decision to be made by the Competent Authorities of individual Member States and national courts.

>>> Through strategic-regulatory consulting services, Thema’s experts can support you in borderline device classification based on the handbook and in fulfillment of the requirements of the MDR Medical Devices Regulation (EU) 2017/745 and IVDR In Vitro Diagnostic Devices (EU) 2017/746.

Contact us for more info!

Source:

https://health.ec.europa.eu/system/files/2022-09/md_borderline_manual_09-2022_en.pdf