Revised EU Manual on Device Classification

Version 4 of the Manual on Borderline and Classification for Medical Devices was published in September by the European Commission’s Medical Device Coordination Group. Our Life Sciences Regulatory team explores how the updated Manual aims to provide additional clarity for borderline products under the European regulatory framework.

What you need to know

• The Manual provides clarity where borderline products are concerned. It provides useful case examples to determine whether a product is classed as a medicinal product or a medical device.
• The Manual emphasises the principle that if a product’s intended action is pharmacological, immunological or metabolic, it cannot be classed as a medical device.
• The Manual will continue to be updated while further cases are finalised by the MDCG’s Borderline and Working Class Group.

In the constantly changing regulatory landscape, governed by the EU Medical Device Regulation (MDR)^[1] and the In Vitro Diagnostics Device Regulation (IVDR)^[2], access to clear information is essential. This is particularly true where borderline products are concerned.

Borderline products are cases where it is not clear whether a specific product is classified as a medical device, an in vitro diagnostic device (IVD), or a different type of product. Once a product is classified as a medical device, a risk class will be assigned to it, namely class I, IIa, IIb or III. For a product classified as an IVD, the risk classes are A, B, C and D.

The Medical Device Coordination Group (MDCG) published the fourth version of the Manual on Borderline and Classification for Medical Devices under Regulations (EU) 2017/745 and (EU) 2017/746 in September 2025.

The latest updates, including the addition of new case examples, are published on the official EU website, typically in September each year. These updates are part of the Helsinki Procedure; a collaborative process involving national competent authorities to resolve ambiguous cases. The aim of the Helsinki Procedure is to ensure consistent application of classification rules across EU Member States. The Manual records the decisions made by the MDCG’s Borderline and Classification Working Group (BCWG) under the Helsinki Procedure, as provided for in the MDR and the IVDR. The Manual is updated from time to time as further decisions under this process are reached. The Manual will continue to be updated as cases are finalised by the BCWG under the Helsinki Procedure.

Purpose of the Manual

Determining whether a product is a medical device, an IVD or a product which falls outside the scope of the MDR and IVDR is often the first regulatory decision when placing a borderline product on the market. Incorrect classification of a product can lead to serious and costly consequences, including:

• Regulatory delays
• Compromised patient safety
• Compliance risks, or
• Forced market withdrawal

The manual provides clarity on borderline situations and sets out how classification rules should be applied consistently throughout EU Member States. The Manual serves as a vital tool when preparing classification rationales, although it is not a legally binding document.

The Manual notes the following MDCG classification guidance documents which should be read in conjunction with the Manual:

• MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

• MDCG 2019-11: Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

• MDCG 2021-24: Guidance on classification of medical devices

• MDCG 2020-16: Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746

Case examples from the updated manual

Red blood cell additive actions containing adenine

• Classified as a Class III medical device.

• Adenine is a substance which increases adenosine monophosphate (AMP) in the blood and is used to increase the shelf life of the red blood cells. Its action can be metabolic or pharmacological, as defined in MDCG 2022-5.

• When used in additive solutions for red blood cell processing, adenine acts as an ancillary medicinal substance. As a result, the device should therefore be classified as Class III under Rule 14.

Dual action cream with menthol and capsaicin

• Should not be classified as a medical device.

• According to the manufacturer, the product is a dual action cream with cooling and warming effect with menthol, capsaicinoids and some other additional substances. The intended purpose of the cream is relieving muscle and joint pain through dual action. Menthol cools, relieves pain, reduces swelling and reduces muscle tension. Capsicum extract warms the treated area.

• Since the principal effect is pharmacological, the product does not qualify as a medical device.

Comment

While not legally binding, it is highly recommended that manufacturers of medical devices and IVDs familiarise themselves with the views expressed by the MDCG in the updated Manual. The revised edition provides additional clarity on classification questions, particularly for borderline products. This is important for manufacturers as clearer classification of borderline products supports smoother market access and innovation.

The Manual should be read in conjunction with other MDCG documents providing guidance on borderline cases and the classification of medical devices and IVDs.

For more information and expert advice on market access considerations, please reach out to a member of our Life Sciences Regulatory team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.

[1]Medical Device Regulation 2017/745

[2]In Vitro Diagnostic Medical Device Regulation 2017/746