Just under two years from now, on 26 May 2020 the new Medical Devices Regulation (MDR) will apply in the EU. Companies are already preparing, and with the rise of digital health solutions highlighted by the recent eHealth Communication many will encounter bigger opportunities or stricter market access requirements than they thought. Luckily, the Court of Justice of the EU (CJEU) has set out part of what we can expect – and medical devices businesses should take careful note.

Andrea Tognoni
Consultant

The CJEU has clarified the criteria to consider standalone software as a medical device under the Medical Devices Directive (MDD), where the definition of medical devices is the same as the MDR so will continue to apply. With the increased use of data and automated decisions support in healthcare, it provides medical technology manufacturers and other healthcare stakeholders like insurers and payors with precious guidance on how their market access will look like.

In Case C-329/16, the French medtech association and Philips France had challenged a ministerial decree that required a national certification for software providing information on drugs’ contraindications and interactions to assist doctors their prescription and dispensation. The CJEU ruled that this standalone software qualified as medical device, so it was subject to the MDD, therefore its further certification beyond CE marking violated EU law.

True, the definition of medical device in the MDD already includes software, so no big news there. But the CJEU specified why and how so, explaining that the software at issue satisfied two conditions. First, it is not enough for the software to be used in medical context or merely aim at archiving, collecting and transmitting health data. It needs to have ‘medical purpose’ as expressly defined by the manufacturer. And second, that it acted on the human body not by pharmacological, immunological or metabolic means – thus the action carried out by the software does not need to act directly or indirectly in or on the human body.

This ruling has at least two very interesting implications for the medtech industry, notably in terms of their planning and budgetary burdens for software manufacturing and entry to market.

Firstly, software doing more than simply storing/archiving data, which aims at monitoring, preventing or treating diseases by interpreting or cross-referencing data (in this case automatically crossing drugs information with patient data to check contraindications, interactions or dosages) should be regarded as a medical device under the MDR. Therefore, this classification may include and affect several healthcare apps – think of the tighter criteria to be included in Class 1 under the MDR. This means that putting a software on the market may require the involvement of notified bodies or conformity assessments, and possibly shift liabilities between the manufacturer and healthcare professionals using the product.

Secondly, to reflect the CJEU ruling the French Conseil d’Etat will need to amend the challenged decree on reimbursement of prescription support software. This points to the fact that the different approaches of EU Member States on these tools for health data management might soon be made more consistent – likely starting with the new Commission guidelines, expected this year. Moreover, classification of software as medical device means that certain software might be submitted to Health Technology Assessments (HTA) as well as subject to the ensuing pricing/reimbursement decisions in different ways depending on their classification. As HTA is also being reformed to achieve more cooperation at EU level, this interrelation will be one to watch.

In the next two years the health software market is likely still evolve – perhaps as rapidly as the data policy landscape. We look forward to further clarity on how the growing, ubiquitous importance of data might give rise to requirements and standards for software dealing with people’s health data.