In September 2022, the Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device Coordination Group (MDCG), issued a manual to determine whether a particular product qualifies as a medical device or in vitro diagnostic and into which class a particular medical device or in vitro diagnostic falls. The MDCG is operating under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).
In more detail
The manual is a non-binding guideline and aims to prevent different product classifications across Member States. A similar manual had been issued previously under the Medical Devices Directives1 but needed revision in light of the new definitions, classification rules and operation of the MDCG under the MDR and IVDR.
The new manual is dynamic and will continue to be updated with the outcomes of Member States’ consultations for specific products and categories of products. It needs to be read in conjunction with other guidance issued by the MDCG on borderline products and classification.2
Despite the drive for harmonization with the EU, there are still today products with different statuses across Member States or even within one Member State (e.g., macrogol-based laxatives3).
For those products that have previously been classified as medical devices under Directive 93/42/EEC, there is a likely need to re-certify under the MDR. In such cases, a notified body may call into question the status of the product as a medical device and seek the opinion of the national competent authority. Such national competent authority in turn may consult with other Member States in the BCWG. If the national competent authority decides to assign the product to another product category (say medicines), the consequences are significant: not only are the approval pathways and the required evidence very different but also the marketing, supply, post-market surveillance, etc., will all be governed by very different rules. Of particular relevance are any pricing and reimbursement implications as pricing of medicines are typically impacted when generic competition sets in; such price erosion does not affect medical devices in the same way and revenue could be severely impacted through reclassification.
1 Medical Devices Directive (93/42/EEC); In Vitro Diagnostic Medical Devices Directive (98/9/EC) and Active Implantable Medical Devices Directive (90/385/EEC).
2 Guidance on the borderline between medical devices and medicinal products (MDCG 2022-5); Guidance on classification of medical device (MDCG 2021-24) and the Helsinki Procedure. The latter procedure has existed since 2002 but was revised in 2021 to align with the MDR and IVDR. It allows consultation among competent authorities on borderline and classification issues concerning medical devices with the aim of encouraging common positions. It also ensures that appropriate guidance is published in the manual on borderline & classification for medical devices.
3 Cfr. Macrogol Cases I and II – German Bundesgerichtshof – judgements of 12/10/2009 and 11/24/2010.