EMA Updates Q&A on MDR, IVDR

Regulatory NewsRegulatory News | 22 October 2019 |  By 

The European Medicines Agency (EMA) on Tuesday released an updated and revised questions and answers (Q&A) document on the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

The Q&A, first released in February, includes new sections on the basics of regulating combination products and selecting a notified body, as well as other issues like the impact of MDR on a Mutual Recognition Procedure (MRP) and whether the unique device identifier (UDI) requirements are applicable to integral Drug-Device Combinations (DDCs).

On the topic of submitting an application for the MRP/Repeat Use Procedure (RUP) on or after 26 May 2020, which is the date MDR takes effect, EMA explains that if the authorization includes an integral medical device then the General Safety and Performance Requirements and Article 117 of the MDR “will need to be met and the supporting documentation such as the Declaration of Conformity, certificate of conformity or notified body opinion should be included in the dossier.”

The Q&A also notes that a variation application to add a new notified body opinion, declaration of conformity or certificate to formally update the dossier “will be required in the reference member state and, where applicable, existing concerned member states before the commencement of the Mutual Recognition/Repeat Use procedure.”

But for integral DDCs, the EMA also notes that if the device is governed by the medicinal products legislation, then MDR obligations related to UDIs “are not required and should not be applied to the package of the combination product,” as discussed in UDI guidance from February.

Revised sections of the EMA Q&A include further clarity on whether Article 117 of MDR impacts currently authorized integral DDCs, when it’s required to provide the notified body opinion/EU certificate/declaration of conformity with a Marketing Authorization Application (MAA) and how MDR and Article 117 will impact new MAAs.

“Devices certified by a notified body can benefit from a transition period provided for in MDR Article 120 (2), which allows devices with a valid certificate under the Medical Device Directive 93/42/EEC (MDD) and Active Implantable Medical device Directive 90/385/EEC (AIMDD) to be placed on the market up to the latest 27 May 2024, although they will need to comply with certain requirements of the MDR from 26 May 2020 (see FAQ’s published by the CAMD MDR/IVDR transition subgroup: FAQs – MDR Transitional provisions),” the Q&A adds.

It also says that self-declared Class I devices “must be in compliance with the MDR by 26 May 2020.”

Duncan McPherson, clinical director of devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), told attendees at RAPS’ Convergence in September that a proposal has been submitted to the European Commission to change the timetable for Class I reusable devices, including some software, that are being upclassified.

Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (With Track Changes)


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