In the intricate landscape of medical devices, determining the classification and borderline status of a product is a crucial yet intricate task. The delineation between what constitutes a medical device, an in vitro diagnostic medical device (IVD), or other products often requires thorough scrutiny. This determination is pivotal as it dictates the applicable regulations and standards that ensure both public health safety and the integrity of the internal market within the European Union (EU).
Within the EU, the responsibility for defining whether a product qualifies as a medical device falls upon the authorities of the Member States where the product is placed in the market. However, divergent interpretations of EU legislation can potentially jeopardize public health and create distortions within the internal market. Recognizing these concerns, fostering a dialogue among regulators becomes imperative.
The Manual, formulated through the collaborative efforts of the Borderline and Classification Working Group (BCWG), documents the consensus and agreements among Member State members. The BCWG, overseen by the European Commission, comprises representatives from all Member States' competent authorities, with stakeholder associations serving as observers. This concerted effort aims to provide clarity and uniformity in interpreting Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) through what is known as the Helsinki Procedure.
The Helsinki Procedure delineates the process and operational framework, ensuring consistent interpretation and application of regulations concerning the borderline and classification of medical devices and IVDs. Borderline cases, where a product's qualification as a medical device or IVD isn't immediately evident, are addressed under Article 4 of the MDR and Article 3 of the IVDR, alongside pertinent sections under Article 1, specifying the regulations' subject matter and scope.
This manual, while detailing agreements reached within the BCWG, is complemented by other guidance documents such as MDCG 2022-5 on borderline cases between medical devices and medicinal products and MDCG 2019-11 on software qualification and classification.
Once a product is classified as a medical device or IVD, its risk class (I, IIa, IIb, III for medical devices and A, B, C, D for IVDs) is determined. The classification process, as outlined in MDR Article 51 and Annex VIII, involves assigning risk classes to medical devices, and IVDR references Article 47 and Annex VIII for IVDs. Challenges arise when implementing these classification rules uniformly across Member States, prompting the need for the Manual's guidance.
To complement this Manual, guidance documents like MDCG 2021-24 on medical device classification and MDCG 2020-16 on classification rules for in vitro diagnostic medical devices further aid in understanding classification nuances.
In conclusion, the Manual serves as a cornerstone for harmonizing interpretations of regulations governing medical devices and IVDs. It underscores the significance of a collaborative dialogue among regulators and the essential participation of diverse stakeholders. By fostering coherence and clarity, this collaborative effort aims to safeguard public health while facilitating a fair and transparent internal market for medical devices within the EU.