MDR 2nd Corrigendum: 'Up-Classified' Class I Medical Device Extension Finalised & Latest

ARQon
Dec 25, 2019
3 min read

Updated: Feb 14, 2020

MDR 'Up-Classified' Class I Medical device Extension

European Parliament finalized the EU MDR Second Corrigendum following ENVI and INTA committees announcement on Monday 16 December 2019 and published the Second Corrigendum on 17 December 2019. Click here for the announcement and the MDR Second Corrigendum.

The MDR Second Corrigendum updates focusing mainly on transition extension for:

Class I devices that is 'up-classified' under the MDR Annex VIII

Software (rule 11),
Devices with nanomaterial (rule 19),
Inhalers (rule 20),
Substance based devices (rule 21) and
Re-usable surgical instruments.

These 'up-classified' devices will have further transition period under Article 120 (3) and (4) MDR to be placed on the market before 26 May 2024 and can be sold to end user until 26 May 2025, with the following conditions:

manufacturer has a valid declaration of conformity on the products before 26 May 2020.
there is no significant change to intended purpose or design to the device
the device must still complies to Article 120 (3) MDR, relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and the relevant directive, and.
the device must be covered by MDR CE certificate that a notified body must issued by 26 May 2024, if continue to sell to end-user until 26 May 2025.

Article 120(3) read: '3. By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues …'.

Article 120(4) read: '… on the market from 26 May 2020 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.'

Further minor edits, corrections and additions to Article 78(8), Article 84, Article 88(1), Article 120(8), Article 122, Annex I and Annex III.

This extension will allow the first time Manufacturer of the Class I 'up-classified' medical device to have more time to prepare for the EU MDR Notified body conformity assessment, similar to the previous transition given to the the existing Manufacturer with medium and high risk device are allowed to extend to May 2024. Relieve news to all the Class I 'up-classified' medical device's manufacturers!

LATEST NOTIFIED BODIES

DEKRA was recently added to the Notified body list of EU MDR and EU IVDR.

LATEST EU MDR/IVDR GUIDANCE

Key documents below were released such as Class I, Software, UDI guidances for MDR.

MDCG 2019-15 Guidance notes for manufacturers of Class I Medical Devices
MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
MDCG 2019-14 Explanatory note on MDR codes
GS1 Basic UDI-DI, HIBCC Basic UDI-DI, ICCBBA UDI HRI & AIDC Formats, HIBCC UDI HRI & AIDC Formats, ICCBBA Basic UDI-DI, IFA Basic UDI-DI, IFA UDI HRI & AIDC Formats, GS1 UDI HRI & AIDC Formats
Ongoing Guidance development within MDCG Subgroups
Flyer - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Designating authority's final assessment form: Key Information (EN)
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

LATEST MDD/AIMDD GUIDANCES

Key documents below were released such as vigilance reporting guidelines.

MEDDEV 2.12/1 rev.8
Device specific vigilance guidance :
Cardiac ablation vigilance reporting guidance
Coronary stents vigilance reporting guidance
Cardiac implantable electronic devices (CIED)
Breast implants
Manufacturer Incident Report (MIR) Form (add IMDRF code, Similar incidents, SRN, UDI)
Manufacturer Incident Report (version 7.2), mandatory by Jan 2020 or end March 2020 if IT system involved