2022 Medical device news and industry updates

Latest news updates

15 December 2022

Regulation Transitional Changes & Annex XVI Update >

Following the EPSCO meeting on 09 December 2022, BSI is pleased that the European Commission has indicated that they intend to bring forward legislation to extend the date by which medical devices must fully comply with the requirements of the EU Medical Device Regulation (MDR).

02 December 2022

MDSAP Revision of MHLW MO169 >

On March 26, 2021, MHLW MO169 was revised to align with the updated ISO13485:2016, with a transition period of 3 years for manufacturers.

01 December 2022

MDSAP Revision of Brazilian Regulatory Requirements >

On May 2nd, 2022, RDC ANVISA n. 16/2013 - Good Manufacturing Practices and RDC ANVISA n. 23/2012 have been revised as follows: RDC ANVISA n. 665/2022 - Good Manufacturing Practices and RDC ANVISA n. 551/2021, with the transition period starting immediately.

01 November 2022

MHRA on UKCA Standstill Period >

On 21st October 2022, the MHRA officially announced a twelve-month extension to the current standstill period to comply with UKCA marking regulations.

17 October 2022

MHRA's consultation response on future UKCA legislation >

The MHRA consultation response indicates the UK Government’s thinking on the direction of the future legislation – but to be very clear; it is not definitive and not legal yet.

01 June 2022

MDR Technical Documentation submission guidance >

Following our communication in March 2021 on Technical Documentation submission timelines, we now have additional updates we would like you you to read

16 March 2022

UKCA Marking >

From 1 January 2021, medical devices/IVDs must be registered with the MHRA before being placed on the UK market irrespective of whether UKCA marked or CE marked.

11 March 2022

Regulatory Services (Medical Devices) statement on Russia 11 March 2022 >

The Regulatory Services Division of BSI Group regretfully has had to make the decision to discontinue its services in Russia.

04 February 2022

Impact of Change to IVDR Transition Periods >

Further to the client communication issued on 24 November 2021 regarding Transition timelines for IVDD, BSI is contacting you as a Legal Manufacturer with devices certified under the IVDD.

20 January 2022

Unannounced Audits (UAs) onsite >

BSI would like to advise you that we are now resuming Unannounced Audits (UAs) onsite, considering governmental travel restrictions per geography.

10 January 2022

Thank you for 2021, and best wishes for the year ahead >

A warm welcome to 2022. I hope you were able to enjoy the break despite the many disruptions faced around the globe, impacting the ability to celebrate and see family and friends.