The European Commission’s Borderline and Classification Medical Devices Expert Group has published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. The updated manual includes a new section on software and mobile applications reflecting the growing industry of medical device software. The manual also provides new guidance on the classification of two distinct borderline medical device-medicinal products, namely, a riboflavin solution for the treatment of keratoconus and dentistry products with aluminium chloride used in haemostasis.
The latest version of the manual does not introduce any substantive changes to EU medical devices guidance. In the context of borderline software and mobile apps, the manual simply refers to the Commission’s 2012 MEDDEV Guidance 2.1/6 entitled Guidelines on the qualification and classification of stand-alone software used in healthcare within the Regulatory Framework of Medical Devices. The updated manual does, however, provide classification guidance for three specific mobile apps:
(i) an app for processing ECGs that is intended to allow for more timely and accurate diagnosis and treatment of a patient (standalone class IIA medical device);
(ii) an app for storing data on contractions during delivery that is intended to improve the quality of communication between the patient and caregivers (not a medical device); and
(iii) an app to view illustrations of the anatomy of the human body that is not intended to be used directly for the medical benefit of individual patients (not a medical device).
The updated manual also provides classification guidance for two borderline medical device-medicinal products, where the key question is whether the product achieves its mode of action primarily through physical means (medical device) or through pharmacological, metabolic or immunological means (medicinal product):
(i) dentistry products containing aluminium chloride used in haemostasis (medical device); and
(ii) a riboflavin solution for the treatment of keratoconus (medicinal product).
Importantly, although the manual is a useful guidance tool for the classification of borderline medical device products, it is not legally binding. Following the ruling of the Court of Justice of the European Union in case C-109/12 (see our previous post discussing the judgment), Member States may reach a different view on the classification of a borderline product on a case-by-case basis, taking into account all the characteristics of the product.