The COVID-19 also affected the regulatory system of medical devices. In fact, in the face of the health emergency, the European Commission has presented a legislative proposal to postpone for one year the date of application of the new regulation on medical devices.
The decision was taken due to the fact that due to the pandemic, it would not have been possible to ensure that the activities necessary for the proper implementation and application of EU Regulation 2017/745 (MDR) by member states and their health institutions could not be carried out. It will therefore be applied from 26/05/2021. This means that devices already placed on the market under Directive 94/42/EC (MDD) may continue to be made available on the market or put into service until 26/06/25 (Art. 120 of Regulation 2017/745). The issue of new certificates in accordance with the Directive currently in force will therefore always be possible until 26/05/2021.
However, there are a number of requirements introduced specifically by the new regulation which will have to be met from 26/05/2021 onwards. These include surveillance procedures, the presence of the person responsible for the regulation and the UDI system for the identification of medical devices. In particular for the mandatory presence of the UDI code on the label, the date of application varies according to the class of the device itself: from 26/05/23 for Class IIa and Class IIb devices and from 26/05/25 for Class I devices. For implantable and Class III devices, the current provisions of the Regulation remain valid: for implantable devices and devices belonging to Class III […], it shall apply from 26 May 2021.
Regulation vs. Directive
Unlike the Directive, when we speak of Regulation, we mean a regulatory act that is mandatory in all its elements and immediately applicable in the laws of the Member States. The Regulation 2017/745, on the basis of the technological background acquired since the drafting of the previous Directive, addresses the regulation of medical devices in a more explicit, direct and detailed way, correcting some aspects. This is the example of software, until now treated only marginally. Starting from the simple definition of software for medical use up to the mode of classification, several are the unclear aspects of the old Directive.
There are several changes introduced by the new regulation compared to Directive 93/42/EEC. The most important ones are listed below.
Field of application
The definition of medical device is extended to include devices that are not intended for medical use (e.g. tinted contact lenses).
Some of the classification rules in the previous Directive are amended and new ones are inserted in order to make the classification criteria stricter and more precise. For example, the classification of software has become necessary due to its increasing use. They must therefore be considered and regulated effectively, aligning the law with technological and market developments.
Safety and performance requirements
New requirements have been added to the Directive, some have been expanded, some have been rewritten and some have been updated (e.g. requirement on cybersecurity (software and network risks). In fact, we move from “essential” requirements to security and performance requirements. Generally speaking, more detail is required in the technical documentation to be produced.
Introduction of a “person responsible” for compliance with the regulations
The manufacturer must identify at least one person within their organisation who will be responsible for all aspects of compliance with the requirements of the new MDR, who has certain characteristics (technical degree and at least one year of regulatory experience related to medical devices or 4 years of experience in the field).
Implementation of the unique device identification system (UDI)
The UDI system is introduced with the aim of increasing the manufacturer’s ability to track devices in the supply chain. It is also used for the reporting of serious accidents and corrective safety actions. All medical devices shall be marked with a UDI code as well as a string of 14 alphanumeric or numeric characters that distinguish the device model and the manufacturing unit.
Medical Device Database – EUDAMED
A new single European database is introduced for all Member States and accessible to the public: EUDAMED. It is a database for the UDI system, the registration of medical devices, the registration of manufacturers/manufacturers and importers. EUDAMED will make available to the public summary information on safety and clinical performance (together with relevant clinical data) and market surveillance and surveillance (e.g. accidents). This will allow a high level of transparency, eliminate the different national registration requirements that have emerged in recent years and consequently reduce the administrative burden on manufacturers.
So-called Common Specifications will be implemented, which will have to be taken into consideration by both manufacturers and notified bodies, in order to enforce safety and performance requirements in the absence of harmonised standards for that particular type of product. This aspect is still to be clarified.
Strengthening the requirements for clinical evaluation
More relevant changes are introduced compared to the previous system: the MDR still provides for the collection of clinical data already available in the literature and the organization of the necessary clinical investigations. The concept of equivalence with other devices for which clinical data already exist can continue to be used, but more restrictive criteria have been introduced to demonstrate equivalence. As a result, most clinical data will have to be obtained from clinical studies, especially for Class III devices.
Tighter after-sales supervision
Greater emphasis is placed on surveillance and after-sales surveillance procedures that become more stringent: further provisions are defined on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market. A periodic safety update report (PSUR) is required for manufacturers of Class IIa, IIb and III devices. In addition, greater authority is given to the competent bodies in post-market surveillance, through unannounced audits, tests and spot checks, in order to strengthen the enforcement regime in Europe and help reduce the risks arising from unsafe devices.
Despite the increased time available, a few question marks still remain. For example, the new European medical device database, EUDAMED, will hopefully be operational from 2022. The same applies to the UDI system, which is currently not yet active.
Another important point concerns Notified Bodies. To date, there are still a limited number of bodies authorised to proceed with the conformity assessment of medical devices under the new Regulation for certification under the new Regulation. The list of Notified Bodies currently approved is shown in the table. The updated list is available on the website of the Notified Bodies database, NANDO: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34.
This means that if the certification process involves a Notified Body, it is advisable to move well in advance to start the procedure, taking into account any delays.
Miriam Di Fonzo – Fabrizio Battaglia