Changes in MDCG guidance – borderline products: medical devices & medicinal products

On October 29, the Medical Device Coordination Group (MDCG) published an updated guidance document, “MDCG 2022 – 5 Rev. 1,” which provides essential updates for categorizing borderline products. These products sit at the intersection of medical devices and medicinal products, and the new revision of the guidelines points out further examples to facilitate the interpretation of the provisions of Regulation (EU) 2017/745 on medical devices (MDR) and Directive 2001/83/EC concerning medicinal products.

Borderline products under MDR

Borderline products are those whose classification as either a medical device under the MDR or a medicinal product under the medicinal products directive (MPD) is not immediately evident. The EU framework aims to ensure that all products on the market are categorized correctly to meet appropriate safety and efficacy standards. MDCG’s guidance document offers critical definitions, examples, and clarifications to assist manufacturers, regulatory bodies, and other stakeholders in making consistent classification decisions.

Borderline products require precise classification since their categorization affects the conformity assessment or marketing authorization processes necessary before market release. These products must undergo a distinct evaluation to determine whether they meet the definitions outlined in Article 2(1) of the MDR for medical devices or in Article 1(2) of the MPD for medicinal products. Generally, a product is regulated by one framework but not both, though cross-references may apply to products with characteristics aligning with both categories.

Medical Device vs. Medicinal Product

The essential characteristic of a medical device is that it should not achieve its principal intended action through pharmacological, immunological, or metabolic means, although these mechanisms may support its function.

Conversely, the MPD defines medicinal products as substances intended for disease treatment or prevention through pharmacological, immunological, or metabolic action. The mode of action often becomes a decisive factor in differentiating between devices and medicinal products. For example, a product achieving its primary purpose through physical interaction may fall under the MDR, whereas one relying on pharmacological activity would align with the MPD​.

Updated Guidelines in MDCG 2022 – 5 rev. 1

The most recent updates in MDCG 2022 – 5 Rev. 1 involve section 1.2.6.1, which addresses products designed for cleaning, disinfection, or sterilization of medical devices. According to the guidelines, such products qualify as medical devices if they are explicitly intended for device preparation. This distinction is crucial as it excludes multi-purpose disinfectants from the MDR, directing them instead under the Biocidal Products Regulation (EU) No 528/2012.

Qualification of medical devices

Determining whether a product qualifies as a medical device requires manufacturers to consider a series of questions. The MDCG 2022 – 5 even before the revision had already proposed a flowchart decision tree to aid this classification process. The first consideration is whether the product serves a specified medical purpose, such as treating or diagnosing disease. If the answer is affirmative, further assessment follows to ensure the product’s intended action does not primarily depend on pharmacological, immunological, or metabolic means, as these would indicate a medicinal classification. Products intended as an accessory or support for medical devices—like lubricants or contact lens care solutions—fall under device accessories​.

Case studies of borderline products

The MDCG provides concrete examples of borderline products to illustrate the application of these regulations. Medical devices often include bone cements, dental filling materials, wound dressings, and certain sterilization solutions. Alternatively, medicinal products encompass spermicides, anesthesia gases, and in vivo diagnostic agents like X-ray contrast media. Specific herbal and substance-based medical devices, as detailed in Sections 3 and 4 of the guidance, add further clarity to these categories​

Substance-based medical devices

A unique classification challenge arises with devices incorporating medicinal substances, particularly those where the substance serves an ancillary role. Under the MDR, such devices may be classified as medical devices, provided their primary action remains physical. Examples include wound dressings that use substances with a minor antiseptic role, contributing only secondary effects that do not alter the device’s primary physical action​.

Implications for manufacturers and Notified Bodies

Manufacturers are required to scientifically justify the categorization of their products, substantiating claims with technical documentation that addresses safety and performance. When a product contains a substance typically considered medicinal, additional scrutiny is applied. Notified bodies play a pivotal role by ensuring a manufacturer’s adherence to MDR stipulations, especially for high-risk classifications that require thorough assessment. The MDR necessitates a documented review of classification criteria, to prevent delays or misclassifications.

For products with an unclear classification, such as those involving ancillary medicinal substances, compliance with MDR and MPD is paramount. MDCG’s recent guidance reflects the EU’s commitment to aligning these frameworks, ensuring that products serve their intended purposes without compromising user safety. This alignment also aids in avoiding duplicate regulatory requirements, streamlining the market entry process for products that meet all legal requirements.

Summary

The MDCG’s guidance on borderline products significantly aids in resolving classification issues, enabling more consistent application of the MDR across the EU. By establishing clear criteria and definitions, the MDCG 2022-5 rev. 1 supports the streamlined categorization of products that occupy the borderline between medical devices and medicinal products. This guidance is instrumental for manufacturers and regulatory bodies, ensuring both regulatory compliance and enhanced patient safety in the EU market.

Link to the document:

https://health.ec.europa.eu/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en.pdf