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.