2. Applicability of Medical Device Regulations


Applicability of Medical Device Regulations

A major role plays the Regulations for Medical Devices, the Medical Devices Regulation (Regulation (EU) 2017/745 [1], (MDR) and the In Vitro Medical Device Regulation (Regulation (EU) 2017/746 [2] (IVDR) (hereinafter for both ‘Regulations’). For DHTs it is a prerequisite to determine whether or not the DHT (hardware or software, stand alone, embedded, accessory, companion technology, etc.) qualifies as a medical device and if so, about its classification (subdivided into four risk classes I, IIa, IIb and III) according to the classification criteria (classification rules) in the Regulations (set out in Annex VIII of the MDR and Annex VIII of the IVDR). This will determine the regulatory handling of a DHT.

Where applicable, a similar classification exercise will be necessary as regards the new rules laid down in the Artificial Intelligence Regulation Proposal if and when adopted (see section ‘Data-driven services and decision support – Example Artificial Intelligence (AI)’).

Specifically for software (a set of instructions that processes input data and creates output data) falling within the scope of the MDR and the IVDR, the Medical Device Coordination Group (MDCG)* provided guidance:

      • defining the criteria for the qualification of software
      • on the application of classification criteria for software under the regulations (MDCG 2019-11)**.
      • on how manufacturers are expected to fulfil the relevant general safety and performance requirements of Annex I to the MDR and IVDR on cybersecurity (MDCG 2019-16)***.

*  The Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified  Body oversight or standardisation to market surveillance, passing by international matters, new technologies and clinical investigation.

** MDCG 2019-11 Guidance on Qualification and Classification of Software in the MDR and IVDR

*** MDCG 2019-16 Rev.1 Guidance on Cybersecurity for medical devices

A qualification submission should provide insight into the reliability, accuracy, precision, clinical validity, generalisability and clinical applicability of the methodology to be qualified. The intended medical purpose of the DHT as described by the manufacturer is relevant for the qualification and classification of any device which entails that any claims, relating to this purpose are supported by clinical evidence.

Digital technologies that fall within the scope of medical devices must meet all the regulatory framework's essential administrative and safety requirement, all regulatory requirements for placing on the market and conformity assessment.

Where a given product does not fall under the definition of a medical device, or is excluded by the scope of the Medical Devices Regulations, other Community and/or national legislation may be applicable.

Medical devices in the European Union are regulated at EU Member State level, i.e. are under regulatory oversight by the National competent authorities (NCAs), but the EMA is involved in the regulatory process (see example below). As such, the MDR and IVDR introduced new responsibilities for EMA and national competent authorities in the assessment of certain categories of medical device. (see also Module 7 of the Open Classroom on Medical Devices) 

Example: CE Marking of Medical Device 

Manufacturers can place a CE (Conformité Européenne) mark on a medical device after it has passed a conformity assessment. For the manufacturer, the conformity assessment usually involves an audit of the quality system and, depending on the type of device, a review of technical documentation on the safety and performance of the device. Member States designate accredited notified bodies to conduct conformity assessments. In some cases, they must seek a scientific opinion from EMA before issuing a CE certificate.

     EMA plays a role in the assessment of:


[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
[2] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices: https://eur-lex.europa.eu/eli/reg/2017/746/oj