The new article provides an overview of the medical device classification rules adopted in the European Union and highlights the key points associated thereto.
Table of Contents
The Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device Coordination Group (MDGC), which is an advisory body of the European Commission (EC) in the sphere of medical devices, has published a manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The document describes the approach to be applied concerning the classification of medical devices under the new regulatory framework set forth by the aforementioned Regulations. At the same time, the document itself is non-binding in its legal nature, nor is intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. It is explicitly stated that the present document should not be construed as describing the official position of the EC. Furthermore, the MDCG reserves the right to make changes to the document and recommendations provided therein, should it be reasonably necessary to reflect corresponding amendments to the underlying regulations.
Regulatory Background
Under the general rule, 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. At the same time, the MDCG acknowledges that different interpretations of the applicable classification rules and respective regulations could result in discrepancies in the approaches followed. Thus, the MDCG finds it important to establish a generally accepted approach to be followed by all the parties involved in operations with medical devices in the EU. The present document describes the agreement reached by the Member States following the exchanges under the Helsinki Procedure under the MDR and IVDR.
Scope in Detail
The matters related to the borderline between the products subject to regulation under the framework of the medical device, and the ones falling outside its scope, also referred to as qualification of a product, are addressed in Article 4 of the MDR “Regulatory status of products” while similar rules related to in vitro diagnostic medical devices are described in Article 3 of the IVDR. According to the manual, 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. Furthermore, it is stated that some of the provisions contained in other articles of the Regulations could be applied as well – the ones that outline the products excluded from the scope of the Regulations. However, in certain cases, even in case the product in question does not meet the definition of a medical device, or is explicitly excluded from regulation under the Regulation, other EU-wide rules or national regulations could be applicable – these cases are not covered by the present manual, which describes only the aspects related to the application of qualification rules set forth under the Regulations.
The document further refers to the MDCG Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices; and the respective guidance on Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
The applicable regulations also provide that once it is determined that the product in question is a medical device, a risk-based classification should be performed, resulting in the appropriate risk class assigned to the device (from I to III). In case the product subject to review is an in vitro diagnostic medical device, the risk classes to be applied are A, B, C, and D. As it was mentioned before, in certain cases it becomes difficult for the competent authorities of the Member State to follow a uniform approach for the application of medical device classification rules. The way classification rules should be applied for various medical devices is described in detail in the appropriate guidance documents issued by the MDCG, namely:
- MDCH 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.
It is further stated that the recommendations provided in the present manual are not exhaustive, so the competent authority should make its decision on a case-by-case basis, considering the specifics of the product in question.
In summary, the scope of the manual issued by the BCWG covers the aspects related to:
- Qualification of medical devices, which stands for the initial determination of their regulatory status (whether the product in question should be subject to regulation as a medical device). In particular, the document describes qualification rules to be applied to distinguish medical devices from medicinal products, biocides, and personal protective equipment. Apart from this, the document describes the way in vitro diagnostic medical devices should be distinguished from general ones and general laboratory equipment.
- Classification rules for both general medical devices and IVDs.
Thus, the present manual is intended to assist medical device manufacturers and other parties involved in determining the regulatory status of healthcare products intended to be marketed and used in the US. The document explains the approach to be applied concerning borderline products and provides qualification rules to be followed.
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