On the 7 September 2022, the European Commission announced publication of the latest manual on borderline and classification in the community regulatory framework for medical devices and In Vitro Diagnostic medical devices (Borderline Manual).
This is the first version of the manual published under the requirements of the EU Medical Device Regulation (MDR). The introductory text states that it should be read alongside other guidance documents available regarding borderline products, including 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. Reference is also made to consideration of recent guidance documents covering 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 format of this new manual differs from the previous borderline and classification document issued under the Medical Device Directive (MDD); Version 1.22, May 2019. Due to the changes to a number of classification rules under the MDR, the existing borderline assessments undertaken under the MDD—amounting to more than 100 product types—have not been migrated.
The latest manual is divided into two parts, the first covering products regulated under the MDR, and the latter, for those under the scope of (EU) 2017/746 covering IVDs. Within each section, there are sub-parts discussing the qualification of subject devices and the respective classification rules. Compared to the previous manual (MDD), a number of additional borderline areas have been introduced, including the borderline between medical devices and: substances of human origin; food; PPE; and general consumer products. There is also consideration to the borderline between IVD products and general laboratory equipment.
- There are a total of 11 borderline cases: ten covering medical devices and one an IVD presented in the first version of the manual.
- Two notable assessments include one for implantable dermal fillers and another for ethylene oxide (EtO) gas cartridges.
- The outcome regarding implantable dermal fillers concluded that since these materials are administered by injection, dermal fillers that are wholly or mainly absorbed are covered by rules 7 and 8 of Annex VIII of the MDR (depending on their intended duration of use).
- The assessment of the EtO gas cartridges relates to the use of these products specifically for the sterilisation of medical devices in healthcare institutions, rather than commercial sterilisation facilities. This outcome concluded that such products are covered by Rule 16 of the MDR and are, therefore, classified as at least Class IIa medical devices.
Moving forward, the new manual will be expanded as further agreements are reached by EU Member States of the Borderline and Classification Working Group (BCWG). These assessments are conducted in accordance with the Helsinki Procedure under the MDR and IVDR. This procedure provides detailed flowcharts and accompanying commentary. It is noted that the typical duration for this procedure is approximately six months.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for manufacturers. In fact, many of our Associates have previously held positions within these organizations, which provides Clients the benefit of a clearer understanding on how to proactively plan for international requirements and expectations.
NAMSA is here to provide assistance on the following, and many other areas of EU medical device development:
- Have you developed or do you market a borderline medical device or IVD product?
- Do you require support to establish the classification of your device?
- Has your device classification been affected by the transition from the MDD to the MDR?
- Is your device classified correctly?
Sign up for your complimentary consultation with one of our experts today to learn how NAMSA can help you accelerate your development outcomes: https://namsa.com/namsa-expertise/subject-matter-experts/.
Or, learn about NAMSA’s full suite of Regulatory and Quality services and solutions, including MDR compliance planning, at: https://namsa.com/services/regulatory-and-quality-consulting/.
David Mandley, PhD
David joined the Regulatory Consulting Team at NAMSA in 2021 and currently serves as a Principal Regulatory Consultant. Mr. Mandley has more than 20 years’ experience in the medical device industry working with a range of product types and organisations from university spin-outs to multinationals. Following completion of his doctoral research in Applied Photochemistry at Loughborough University, David held various roles for a UK-based SME, Tissuemed, including Research & Development, QA, RA—culminating into serving as CEO for eight years. During this period, David was pivotal in the development, regulatory approval and commercialisation of a range of implantable, resorbable surgical sealants indicated as adjuncts for the prevention of intra- and post-operative leaks, including air, blood and cerebral spinal fluid. More recently, Mr. Mandley has worked as a regulatory consultant for a range of multinational medical device manufacturers, leading MDR submissions for a variety of device types and classifications (I – III) from wound care devices and their accessories, combination products and radiofrequency ablation systems.