A Long-Awaited Political Handshake on EU Medical Devices Regulations Leaves Residual Uncertainty

Following four years of negotiations, political agreement on the EU’s new rules on medical devices and in vitro diagnostic medical devices (IVDs) has now been announced. The rules represent a significant overhaul of the current legislative framework applicable to the EU’s 25,000 medical devices manufacturing companies, and will have a far-reaching impact on all operators within the medical devices sphere, including in particular mHealth providers.

The regulations remain subject to the approval of the European Council’s Permanent Representative Committee and the European Parliament's Committee on Environment, Public Health and Food Safety. That approval is expected by mid-June 2016. The regulations will then be subjected to a linguistic review and formally adopted by the Council and Parliament. Once this process is complete, the final texts of the regulations will be made public.

The rules will be in the form of two regulations, one each for medical devices and IVDs. Existing legislation in this field consists of a series of directives, which require the enactment of nationally implementing measures to take effect. Such national measures are not always consistent as between different EU Member States. It is hoped that the new regulations, which are directly effective in all EU Member States, will result in a more harmonised regulatory approach throughout the EU.

Some of the changes that are likely to be introduced as part of the new legislative regime applicable to medical devices are as follows:

• Manufacturers will be required to place unique identifiers on their medical devices to ensure traceability.
• The rules for re-processing of single-use devices will change to ensure that such devices are suitable for further use.
• A European database on medical devices (Eudamed) will be created. Registration on the database will be mandatory for any manufacturer or importer who intends to place medical devices on the EU market.
• Obligations, similar to those currently seen within the medicinal products’ pharmacovigilance arena, will be introduced with respect to medical devices. For example:

  • Serious incidents in connection with the use of medical devices will need to be reported by manufacturers to a centralised EU database.
  • The introduction of a post-market surveillance will also require medical devices manufacturers to, for example, prepare annual periodic safety update reports (PSURs).
  • Notified bodies will be required to carry out unannounced inspections of medical devices factories.

The types of products covered by the proposed regulations is wide in scope: from medical-purpose mobile apps, sticking plasters, contact lenses and genetic tests to pacemakers and X-ray machines. Depending on the final version of the text, some aesthetic and other ‘non-medical’ devices, as well as products with only ‘indirect medical effects’, may also come within the new regulations.

Operators in the mHealth space, including those whose products might be regarded as only having a general health-related effect or purpose, should remain alert to developments in this area. A raft of products, which are currently unregulated under the EU medical devices legislation, are likely to become subject to the new rules. However, with regard to mobile apps in particular, there is a degree of residual uncertainly as to which apps will be covered by the new medical devices regulations. As discussed in a recent Arnold & Porter advisory, the European Commission has made clear in draft Guidelines that certain categories of apps will not be covered by the medical devices regulations, including “clinical decision support tools for diagnosis/treatment recommendations” and “point-of-care diagnosis, monitoring or treatment aids”. Meanwhile, the European Council has in its most recent proposal stated that the medical devices regulations should apply to any software “specifically intended by the manufacturer to be used for a medical purpose (as defined in the draft regulations) while software for general purposes, even when used in a healthcare setting, or software intended for well-being application is not a medical device.” On this basis, the line between medical devices (which fall within the scope of the new medical devices regulations) and wellbeing apps (which do not and which instead will be the subject of a discrete regime of Guidelines for assessing data validity and reliability of mHealth apps) does not appear entirely clear-cut. Publication of the final texts of the Guidelines and medical devices regulations will, hopefully, clarify the position.