Is Your Device a Borderline Device?

At the outset it is critical for you as a manufacturer to establish correctly, what is the intended purpose of the device, in order to appropriately define the classification route and all of the requirements that follow, which can be very different for different devices.

The MDD and MDR have slightly different definitions of a medical device but both ultimately lead to the same conclusion in the need to consider the primary mode of action, mechanical (device) or pharmacological (drug/medicinal)1,2. If the mode of action is equally mechanical or pharmacological or cannot be defined, then the medicines regulations (typically) apply.

Some of the products that can be difficult to distinguish include cosmetics, food supplements, biocides, herbal products, machinery and lab equipment.

Considerations for how a drug is delivered must be made and there are cases that the product packaging will also be a delivery device that could be a medical device in its own right (making the combination a medicinal product) and require a technical file, CE marking etc.3, 4

Figure: Inter-relation of medical products inside and outside ‘healthcare’ demonstrating the complexity of overlap between products and technologies



Difficulties arise therefore if registering a medicinal product (following approval via Marketing Authorisation Application (MAA)) with an integral medical device that serves a function of precise delivery, timed delivery, etc. The device must be CE marked and with the notified body and the evidence submitted with the MAA for the device.

Mi3 provide a comprehensive medical device regulatory consulting service and can advise and support your regulatory submissions process from the outset. With Mi3 Quality Management Systems certified and audited to ISO 13485:2016 via the Medical Device Single Audit Programme (MDSAP) we can provide help with defining your regulatory strategy and building the technical documentation needed for your device. MDSAP certification enables us to be one of the few CMO's who can consider the global regulations and requirements to meet your product launch needs.



1.      MEDDEV 2.4-1, Classification ofMedical Devices, Ref. Ares(2015)2068632 - 18/05/2015

2.     MDR(EU)2017/745.


4.     Manual on Borderline andClassification in the Community Regulatory Framework for Medical Devices,Version 1.18, 07/12/2017.

Main image credit to European Commission / MedTech Europe