MDR Delay and Consequences for the UK

Please be advised that on the same day of this original blog posting, 24 April 2020, the MHRA amended the “Medical Devices: EU regulations for MDR and IVDR” which finally provided an official UK update on the delay to full implementation. The details may be found at https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr

The European Parliament, with its infinite wisdom, has voted to accept the European Commission’s proposal to postpone the date of application for the medical device directive until 26 May 2021. Barring a major political catastrophe, the amendment will be published in the Official Journal.

The United Kingdom is no longer represented with MEPs, so therefore did not participate in the vote. Following the transition period, the UK will not be part of the European Economic Union, nor required to abide by EU legislation from 31 December 2020 (at least according to the last Brexit statement by Mr Johnson.)

The MHRA adopted the MDR legislation almost in its entirety, bar a couple of additions. That adoption also included acceptance of 26 May 2020 as date for application. The MHRA guidances “Medical Devices: how to comply with legal requirements” was last updated in Feb 2019 and “Medical Devices: EU regulations for MDR and IVDR” was last updated October 2018. Neither guidance mentions the possibility of the current delay.

Will the MHRA expect adherence to the 26 May 2020 date of application for MDR for medical devices marketed (also would include European imports) in the United Kingdom even though the UK was not represented in the parliamentary vote?

Also, I found it strange that shortly following the delay decision, BSI posted the following on LinkedIn:  https://www.linkedin.com/posts/bsi-medical-devices_brexit-bsi-mdr-activity-6658629726594187264-YC69 The language of the introduction seems to suggest that the video will address the delay, however Dr. Halliday’s video was recorded prior to the EU commissions proposal. The post doesn’t have any comments.

I would very much welcome any feedback on when and/or whether the MHRA will also delay application of the UKs relevant MDR legislation during this transition period. Please email me at kimyoung@instem.com.

I guess we will all need to watch this space.

K Young