As laws regulating medical devices are not fully harmonised in the EU and are in the process of significant change (see below), it is critical that manufacturers, importers and distributors of wellbeing and lifestyle apps understand on which side of the medical devices borderline the products fall in each country where a product is (or is intended to be) marketed and their legal obligations.
The EU regulatory framework for medical devices under the existing regime is governed principally by three EU Directives (Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC). In most cases, Directive 93/42/EEC (the Medical Devices Directive or MDD) will be the most relevant to apps available to the general public.
The EU regulatory framework is in a period of transition. The new regime means a significant overhaul of the existing regime that will place greater responsibilities and liabilities on manufacturers, distributors, importers and other economic operators.
The key question to consider is whether the product falls within the definition of "medical device".
Software is expressly included in the definition of "medical device", so whether the manufacturer intended the product to have a "medical purpose" will be the key distinguishing factor between apps that are consumer goods and those which are medical devices. "Medical purpose" is ascertained by the data supplied by the manufacturer on the labelling, in the instructions for use and promotional material related to a given device (Article 2(1)(g) MDD).
European case law has also made clear that in situations where a product is not conceived by its manufacturer to be used for medical purposes, its certification as a medical device cannot be required. However, if software uses patient-specific data in an automated manner to give patient-specific outcomes, it is more likely to pursue a medical objective and be a medical device.
Useful guidance has been published by regulators to help manufacturers decide whether their software products (including apps) could qualify as a medical device, including guidance published by the European Commission and the UK's Medicines and Healthcare products Regulatory Agency.
If an app qualifies as a medical device, the manufacturer will need to assess which class it is in. There are four classes of medical devices - Class I, Class IIa, Class IIb, Class III – based on risk profile. Class I devices have the lowest risk profile whereas Class III medical devices have the highest risk profile. The classification of a medical device determines the scope of a manufacturer's pre and post-market obligations, including the route to obtaining a CE mark known as the conformity assessment procedure (see below).
General guidance on classification and conformity assessment of medical devices within the EU framework is available on the European Commission's website. For manufacturers planning to launch products in the UK, MHRA's website is another useful source of regulatory guidance.
Two new EU Regulations concerning medical devices and in vitro diagnostic medical devices entered into force on 25 May 2017. Regulation (EU) 2017/745 (MDR) will eventually repeal and replace the Medical Device Directive and Directive 90/385/EEC and will apply from 26 May 2020. See our article in Synapse for further details.
Though the definition of "medical device" in the MDR is a little different from that in the MDD, the intention of the manufacturer remains a key element to the determination of whether a product will qualify as a medical device under the new regime.
The MDR also introduces a new classification rule that applies to standalone software (Rule 11 in Annex VIII), which provides:
"Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb. All other software is classified as class I."
Rule 11 is ambiguous as to its interpretation and application. According to the MDR, if several rules or sub-rules apply to the same device based on its intended purpose, the strictest rule and sub-rule resulting in the higher classification applies. This could give rise a situation where a device might be classified as a Class I medical device under the MDD, but classified in a higher class under the MDR.
The effect of 'up-classification' is that the manufacturer will be subject to more obligations under the MDR and will have to undertake a conformity assessment procedure that involves a Notified Body. A Notified Body is an independent organisation that is authorised to undertake certain regulatory functions relating to certain classes of medical devices.
In general terms, medical devices must be CE marked before they can be marketed anywhere within the EU (see our article about the impact of Brexit on product marking). A CE mark cannot be lawfully affixed to a product unless it has first undergone a conformity assessment and the precise assessment route depends on the classification of the device. However, if a product qualifies as medical device but does not conform with relevant legal requirements, marketing the product within the EU will be unlawful. This could give rise to action being taken by regulatory authorities which, in serious cases, may include criminal sanctions.
It's not just device manufacturers who will need to take account of the new rules. Importers and distributors should also be aware that their obligations under the new regime will increase. With potential added complications around Brexit, all stakeholders will need to keep abreast of new developments.
If you have any questions on this article please contact us.
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