On 26 May 2021 the new EU Medical Devices Regulation was enforced. This follows a transition period since 2017, that was extended for one year due to the COVID19 pandemic. Some special transition provisions are included till 2025.
According to the European Commission, the new regulation “contains a series of extremely important improvements to modernise the current medical devices system”.
Among them are six enhancements that relate to pre-market and post-market activities as well as oversight, traceability, surveillance, transparency and coordination:
- “stricter previous control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at European Union level;
- reinforcement of the criteria for designation and processes for oversight of notified bodies;
- improved transparency through a comprehensive EU database on medical devices and a device traceability system based on a unique device identification;
- reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorising multi-centre clinical investigations;
- strengthening of post-market surveillance requirements for manufacturers;
- improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.”
A focus on software
Focusing on the Digital Health Sector, the new Medical Devices Regulation includes most probably its most drastic change - the provisions for the software medical applications - as compared with hardware-based medical devices.
Although “stand alone software” could be considered as a medical device according to the provisions of the previous Medical Devices Directive (MDD), the Medical Device Software (MDSW) in the Medical Devices Regulation now sets out a number of challenges and opportunities. These are laid out largely in annexes to the Regulation.
The new Regulation clarifies which types of software can be categorised as a medical device.
Such software is: “when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device”.
More details on software
According to Rule 11 of the Medical Devices Regulation Annex VIII:
“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:
- death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
- a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.
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.”
Clinical approaches are key
In Annexes XIV and XV of the Medical Devices Regulation, the procedures for clinical validation are explained in detail. The EC Medical Device Coordination Group (MDCG), established by Article 103 of Regulation (EU) 2017/745, has prepared a manual as a guide for manufacturers and notified bodies regarding the respective clinical evidence required.
Class I non-sterile, non-measuring devices may be self-certified and do not require a CE certificate from an agency, called a Notified Body. For the rest of the classifications however, the certification procedure will be required for medical device software. Among these conformity assessment procedures, Technical Documentation Files and Quality Control Systems are included, as well as a Clinical Evaluation Consultation Procedure for certain class III and class IIb devices.
Artificial intelligence is also crucial
On 21 April 2021, the European Commission proposed the first ever legal framework on Artificial Intelligence (AI), in order to address the risks of AI.
This AI Act (AIA) includes the classification of AI medical applications as “high risk” systems, and includes their certification under the Medical Devices Regulation procedures. Therefore, as soon as the AIA becomes a new Regulation, it is expected to complement the Medical Devices Regulation.
In a nutshell
As a result, the new Medical Devices Regulation offers both challenges and opportunities. On the one hand, these new regulations mean that there are challenges for the digital health sector, given the extra tasks and complexity required for medical device certification. On the other hand, more positively, the increased safety and quality of the certified digital health applications are expected to foster their adoption in the routine clinical sector, and enable growth in the digital health market in Europe.