The MDCG released an important Q&A for manufacturers of Class D devices and their certification during the transition period – until 26 May 2022 or the IVDR date of application. The document is particularly relevant for those types of devices that will undergo an additional scrutiny as part of their conformity assessment procedure, e.g. review by an expert panel or/and test by EURL [EU reference laboratory]. Below an extract of the MDCG Questions & Answers document available also in our Library of Documents – IVDR – MDCG.
Q1. During the transition period, may notified bodies accept applications from manufacturers for certification of class D IVDs, and issue the corresponding certificates, if the IVD expert panel is not yet operational?
Notified bodies may accept and begin the assessment of applications for class D IVDs. However, the notified bodies may not issue the certificate before the expert panel is operational and, for the devices that require consultation of the panel, before the panel has provided its views (see also Q2 and Q3).
Q3. How should the notified body determine whether the device will have to undergo consultation of the expert panel prior to issuing the certificate?
According to IVDR Article 48 (6), “where no CS are available for class D devices and where it is also the first certification for that type of device, the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 on the performance evaluation report of the manufacturer”. MDCG guidance is in preparation on what constitutes a “type of device”, as well as on the process that the notified bodies should follow to determine whether a given certification is the first one for that type.
Q5. During the transition period, may notified bodies accept applications from manufacturers for certification of a class D IVD, and issue the corresponding certificate(s), if an EURL is not designated for that device?
During the transition period, as long as no EURL has yet been designated for that specific device,category or group of device, the notified bodies may accept applications for a class D IVD and issue the corresponding certificate(s).
The European Commission has updated the Implementation Rolling Plan – April 2021 providing a timeline for the adoption of essential acts under both EU MDR and IVDR. The Plan is also available in our Library of Documents – MDR/IVDR – European Commission. The implementation acts together with the expected timelines are enlisted below:
- Common specifications for products without a medical purpose: Q3 2021
- Common specifications for IVD Class D: Q2-3 2021
- Setting up of new structures under IVDR:- EU reference laboratories: Q3 2021-Q1 2022
- Rules to facilitate fulfillment of tasks by EU reference laboratories and to ensure their compliance with criteria: Q2 2021
- Fees for EURL services: Q2 2021
- MDR/IVDR standardisation request: Q2 2021
- After the rejection by CEN and Cenelec of the act adopted by the Commission in May 2020, a new draft Commission Implementing Decision for the MDR/IVDR standardisation request was developed and submitted to the Committee on Standards. A positive opinion was received on 12 March 2021, then the Commission is going to adopt the Implementing Decision and to address it to CEN and Cenelec for their acceptance in 1 month time.
- Harmonised standards in support of MDR and IVDR: Q2, Q3, Q4 2021
- Once the MDR/IVDR standardisation request is adopted by the Commission and accepted by CEN and Cenelec.
- Eudamed: Audit of functional specifications: should be finalised in 2022
Finally, NANDO newly lists Eurofins Expert Services Oy that was notified under the Regulation (EU) 2017/745 on medical devices with the following scope. This makes it the 20th Notified Body being designated to assess devices under the MDR – 44 days ahead of the DoA!
Eurofins Expert Services Oy
PL 47 Kivimiehentie 4
Country : Finland
Phone : +358406311311
Fax : –
Email : FirstnameSurname@eurofins.fi
Website : https://www.eurofins.fi/expertservices
Notified Body number : 0537
Please also note that as of 1 April 2021, the expert panels in the field of medical devices accept submissions from notified bodies for the Clinical Evaluation Consultation Procedure.
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