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Regulatory Focus™ > News Articles > 2020 > 3 > MDCG Offers MDR Implementation Plan, ‘Significant Change’ Guidance

MDCG Offers MDR Implementation Plan, ‘Significant Change’ Guidance

Posted 16 March 2020 | By Zachary Brennan 

MDCG Offers MDR Implementation Plan, ‘Significant Change’ Guidance

While acknowledging the implementation of the new EU medical device and in vitro diagnostic regulations (MDR and IVDR) has proven to be a “very challenging task,” the EU’s Medical Device Coordination Group (MDCG) last week outlined its plan for actions considered essential to have an operational system under MDR in place by 26 May.

Medical device shortages across the region have been chief among the concerns floated by industry and other stakeholders, particularly as there may be insufficient capacity among notified bodies. The MDCG says in its 8-page preparedness plan: “It is difficult to quantify the size of this challenge as no specific data has been presented by the industry.”

And as far as only having 11 notified bodies under MDR so far, the MDCG offered few specifics but said, “It can be reasonably estimated that the number of designated notified bodies will significantly increase in 2020.”

Some legacy devices that were marketed under the previous directives will be afforded a grace period until May 2024, but the MDCG explains that the 55 notified bodies designated under the current directives “have an important role in reviewing and renewing existing certificates, when necessary. Such renewals have to be finalised before 26 May 2020.”

As for the shortage risks related to devices using existing certificates under the directives that would gradually expire after May and not by replaced by MDR certificates, the MDCG says, “The number of devices concerned is difficult to estimate, but information from notified bodies indicate that a vast majority of devices are already engaged in the procedures of certification or have already been re-certified. At this point in time, it has not been possible to receive more precise data. For the medium term, the situation is expected to normalise.”

Evolving relationships between the EU and Turkey, and the EU and Switzerland, also add further stress for some devices.

But one of the priority actions for both Member States and the European Commission is to: “Request regular reporting from industry and notified bodies and monitor market developments and activities performed by notified bodies aiming at detecting possible delays that could lead to shortage of devices on the market.”

As far as other priority areas and actions, the plan discusses the delay of the Eudamed database until 2022, but notes that the European Commission and Member States are working closely on guidance to allow for the exchange of information until Eudamed is functional, particularly in cases when the exchange of information would be difficult to achieve based on the corresponding provisions under the current device directives.

MDCG says it plans to deliver the actor registration module by May 2020 and “an MDCG position paper is under preparation with the aim of explaining the issuing of Single Registration Numbers (SRNs) and to encourage a common approach across the EU to record actors’ data,” the plan says.

In addition, the MDCG also plans to endorse guidance on clinical evidence needed for legacy medical devices and on the equivalence for well-established technologies.

Meanwhile, implementing acts are another area of concern, but some have already been adopted on the designation of the twelve expert panels, the setting of the new unique device identification infrastructure and the list of codes for types of devices for specifying the scope of notified bodies.

“Other implementing acts are under preparation and are expected to be adopted before 26 May 2020, notably the Implementing Decision on a standardisation request to CEN/CENELEC for MDR / IVDR harmonised standards and the Implementing Regulation on Common Specifications for the reprocessing of single-use medical devices. Also the Implementing act on devices without an intended medical purpose (Annex XVI MDR) is in the pipeline,” the plan says.

‘Significant Change’

In addition to the implementation/preparedness plan, the MDCG on Monday released guidance to provide clarification on the changes to a legacy device that should be considered a “significant change in design or a significant change in the intended purpose” under MDR Article 120(3).

Article 120(2) and 120(3) of MDR states that devices which have a valid certificate issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR under certain conditions and no later than 26 May 2024.

To help manufacturers and notified bodies in deciding whether or not a change is to be considered significant in the design or intended purpose of the device under MDR Article 120(3), the 14-page guidance includes six flow charts asking questions related to different factors like performance specifications or software: “Does the change require further clinical or usability data to support safety and performance?” or has there been a change “to a material of human/animal origin including addition of new materials?”

In addition to the new guidance on legacy devices, some are warning that the coronavirus is already hampering the implementation of MDR and IVDR.

The European Association Medical Devices - Notified Bodies (Team NB), said in a statement: “The outbreak is having an impact on the implementation of both regulation MDR 2017/745 and IVDR 2017/746 due to travel restrictions. The impact is also affecting ongoing surveillance and unannounced audits necessary for conformity assessment to existing Directives.”

Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)

Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

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