Manual on borderline and classification for medical devices under MDR and IVDR published
6 January 2023
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.
“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” 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 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.
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 the 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.
The Manual does not relieve national competent authorities from their duty to issue decisions in the areas of qualification and classification for individual products taking into account all its characteristics on a case-by-case basis, while acting under the supervision of the courts.