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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

among regulators.

 

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 MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR).

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

observers.

 

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

that effect.

 

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)

2017/746.

 

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

classification rules.

 

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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