Manual on Borderline
Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of the authorities of the Member
States where the product is on the market. However, when different interpretations of EU
legislation occur, public health may be put at risk and the internal market distorted. As both are
matters of concern to the Member States and the Commission, it essential to facilitate a dialogue
Appropriate participation of various stakeholders should also be ensured.
This document, hereafter called the Manual, records the agreements reached by the Member
State members of the Borderline and Classification Working Group (BCWG) following the
exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices
The purpose and operation of the Helsinki procedure is described in the dedicated document
here. The BCWG is chaired by the European Commission and consists of representatives of
competent authorities from all Member States with a number of stakeholder associations as
The aspects concerning the borderline between medical devices and other types of products,
also known as qualification of a product, are generally governed by Article 4 Regulatory
status of products of the MDR and the corresponding Article 3 of the IVDR. Borderline
cases are those for which it is not clear from the outset whether a given product is a medical
device, or an in vitro diagnostic medical device (IVD), or not. Various paragraphs under
Article 1 Subject matter and scope of both Regulations are also relevant. They exclude
certain types of products from the scope of the Regulations.
Where a given product does not
fall within the definition of medical device or is excluded from their scope, other EU or
national legislation may be applicable. This Manual will however not provide indications to
The Manual should be read in conjunction with other documents providing guidance on
borderline, such as MDCG 2022-5 Guidance on borderline between medical devices and
medicinal products under Regulation (EU) 2017/745 on medical devices and MDCG 2019-11
Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU)
Once a product is qualified as a medical device, a certain risk class will be assigned to it, namely
I, IIa, IIb, III. For a product qualified as an IVD, the risk classes are A, B, C and D. The aspects
concerning classification of medical devices are governed by MDR Article 51 Classification of
devices and Annex VIII Classification rules. For IVDR the corresponding references are Article
47 and Annex VIII. In the context of this Manual, classification cases are those for which the
competent authorities of the Member States identify a difficulty in the uniform application of the
The Manual should be read in conjunction with other documents providing guidance on classification, such as MDCG 2021-24 Guidance on classification of medical devices and MDCG 2020-16 Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746.
Other relevant MDCG guidance documents may be published here.
Entire Manual Can be found by clicking here.
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