Having launched the Actor Registration Module – the first of six planned modules making up the EUDAMED database, the European Commission (the Commission) has begun the process of making a critical component of the regime provided for under the Medical Devices Regulation (MDR) fully operation by 26 May 2021. The In-vitro Diagnostics Regulation (IVDR) will then become fully operational by 26 May 2022.
With the MDR just around the corner, Guidance has recently been published to assist stakeholders in understanding various harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional. We take a look at the story so far and what happens once the Medical Devices Regulation comes into effect in May 2021.
Article 33 of the MDR requires the Commission to establish a European database on medical devices designed to centralise and organise information on medical devices placed on the EU market. Once operational, the six modules making up the system will facilitate the collation and processing of information under the MDR regarding:
Actor registration (operational)
UDI/device registration (scheduled for May 2021)
Notified bodies and certificates (scheduled for May 2021)
Clinical investigations and performance studies (scheduled for May 2022)
Vigilance (scheduled for May 2022)
Post-market surveillance (scheduled for May 2022)
Actor Registration Module
The first of the modules, the Actor Registration Module, provides for the registration of economic operators. Specifically, it requires manufacturers, authorised representatives and importers of MDR compliant devices (Actors) to register their organisations and devices with their Competent Authorities. The Actor Registration Module is a prerequisite for the use of the other EUDAMED modules and facilitates a secure way of accessing EUDAMED.
Using the Actor Registration Module, Competent Authorities in the Member States are responsible for assigning a new single registration number (SRN) to the applicant Actor. An SRN is issued once the information input into the system is validated by the Competent Authority. Economic operators, including manufacturers, system/procedure pack producers, authorised representatives and importers, established within the EU 27, Iceland, Liechtenstein or Norway have therefore been able to submit registration requests in EUDAMED since December 2020. Non-EU manufacturers can also register through their authorised representative established within the EU 27, Iceland, Lichtenstein or Norway. The Health Products Regulatory Authority is designated as the Competent Authority for Ireland.
The European Commission is not in a position to require the use of the Actor Registration Module until EUDAMED is fully functional according to the MDR. However, the Medical Device Coordination Group (MDCG) published a position paper in August 2020 strongly encouraging its use by all relevant Actors, including the use of the SRN by Actors as stipulated in the MDR, e.g. by using the SRN on certificates. Additional national registration requirements are also still possible however, and the MDCG has also noted the agreement amongst its members that double registration requirements for Actors should be avoided as much as possible. Actors that obtain an SRN should therefore be considered in compliance with registration requirements to the extent that national laws accommodate this. Alongside the launch in December, the European Commission has also released a “frequently asked questions” document explaining the registration process.
The full functionality of EUDAMED requires the availability and full operation of all six of its modules and the MDR provides that the obligations and requirements relating to EUDAMED apply from the date corresponding to six months after the date of publication of a notice of full functionality. MDR requirements on the registration of devices and registration of certificates will start to apply 24 months after the date of publication of the notice. Until EUDAMED is fully functional, the corresponding provisions of the Medical Devices Directive and the Active Implantable Medical Devices Directive shall continue to apply for the purpose of meeting the obligations under the MDR regarding exchanges of information. However, exchange of information in the manner required by the MDR would be difficult, and potentially impossible, to achieve based on corresponding provisions of the existing Directives.
In recognition of this, MDCG has published further guidance addressed to Member States and other relevant parties (manufacturers, economic operators, trial sponsors, Notified Bodies and the Commission) that sets out the relevant provisions of the MDR related to EUDAMED along with alternative solutions to submit and/or exchange information as required under the MDR. The alternative solutions relevant to manufacturers that are identified in the guidance are grouped under two main headings:
1. Chapter III: Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Article 29: registration of devices
Article 31: registration of manufacturers, authorised representatives and importers
Article 32: Summary of safety and clinical performance (SSCP)
Article 33: European database on medical devices
Although the alternative solutions contained in the guidance should be carefully reviewed, the guidance under these headings generally advises that EUDAMED may be used for registration purposes as soon as that functionality becomes available (even before the notice of full functionality is published) and nevertheless, manufacturers should refer to national provisions in Member States. The SSCP shall also be made available to the public upon request without undue delay (or the manufacturer shall specify where it is made available to the public).
2. Chapter VII: Post-market surveillance, vigilance and market surveillance
Article 86: Periodic safety update report (PSUR)
Article 87: Reporting of serious incidents and filed safety corrective actions
Article 88: Trend reporting
Article 89: Analysis of serious incidents and filed safety corrective actions
Under these headings the guidance generally states that manufacturers should submit the necessary reports and forms to the respective/relevant national vigilance systems and clarifies what forms are to be used. Manufacturers of class III, class IIa implantable and class IIb implantable devices should also deliver PSURs to relevant notified bodies by “appropriate means”.
The practices and solutions set out in the recent MDCG guidance have been developed with the aim of minimising any potential burden for the parties concerned. However, it remains the case that stakeholders now need to track the various bridging measures set out in the guidance in order to ensure compliance with the MDR in advance of EUDAMED becoming fully operational.
On a more positive note, manufacturers can also take advantage of the phased introduction process by familiarising themselves with the existing guidance and the various modules making up the database as they are introduced. Given the detailed information to be entered, and the care required in order to provide data in an organised and accessible format, learning how to navigate the various parts of the database as they come on stream will also assist in managing the resources required to ensure full adherence with this new system.
For more information, contact a member of our Life Sciences team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.