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Stay up to date with latest news and announcements from BSI and the medical device industry.

Stay up to date with the latest medical device news

You can stay up to date with the latest news and announcements for medical devices through our news updates below and by signing up to our monthly newsletters.

Latest news updates

26 October 2020

Labelling transition from UK to NL >

If you migrated your CE certificates from BSI UK (0086) to BSI NL (2797) then read on to find out what you need to know next.

20 October 2020

United Kingdom Conformity Assessment (UKCA) Your plans >

The MHRA published new guidance on GOV.UK, which sets out how medical devices and IVDs will be regulated after the transition period with the EU has ended (from 1 January 2021).

13 October 2020

BSI Regulatory updates to Microbiology Audits >

Read about how we will be implementing critical microbiology regulatory changes under the EU Medical Devices Regulation (MDR), In Vitro Diagnostics Regulation (IVDR) and Medical Device Single Audit Program (MDSAP).

09 September 2020

UKCA update >

BSI would like to share with you a critical announcement regarding the new UK Conformity Assessed (UKCA) mark for medical devices.

18 August 2020

MDCG 2020-12 >

BSI would like to notify you of the above-referenced document; we believe this is of critical importance to ALL legal manufacturers of products impacted by this guidance.

02 June 2020

Updates to the Technical Documentation Assessment Processes under the Regulations and Directives >

The Technical Documentation (TD) assessment processes is a critical element of conformity assessments under both the Directives and Regulations. Please read more about the increased requirements and how BSI's processes and additional guidance can help you prepare your Technical Documentation.

16 April 2020

Importance of completing Audits during COVID-19 >

As the world faces the COVID-19 pandemic together, we would like to reassure you that BSI has been taking extensive actions to find ways of working in this difficult time.

17 January 2020

BSI issues first Article 117 Notified Body Opinion >

2019 was a year of firsts for BSI. Our UK Notified Body was the first in the world to receive MDR designation, the first to issue an MDR certificate to a client, and the first to receive full-scope designation to the IVDR.

21 April 2020

MDR Date of Application delay confirmed >

On Friday 17 April 2020, the European Parliament adopted the European Commission’s proposal to postpone the implementation of the Medical Devices Regulation (MDR) 2017/745 by 12 months.

27 March 2020

MDR update and COVID-19 impact >

Due to the exceptional circumstances associated with the COVID-19 pandemic, the European Commission is currently working on a draft proposal to postpone the Date of Application of the Medical Device Regulation (MDR) for one year.

27 February 2020

Coronavirus Covid-19 update and impact on assessments >

The situation with regards to the coronavirus disease 2019 (COVID-19) outbreak is evolving rapidly. Please read our latest update on how we are managing global audits and assessments together with an FAQ from our clients on potential impacts.

BSI is now accepting applications for MDR

We can confirm that BSI is now accepting applications under the MDR for our UK Notified Body (0086) from 3 June 2019.

BSI UK Notified Body (0086) will begin to process quote requests and schedule work over the coming months. BSI will provide conformity assessments to the full scope of the MDR. This service will focus on our existing UK (0086) and NL (2797) clients. For further details on BSI’s scope, please visit the NANDO information system.

Who can I contact for further information?
Please contact your Account Manager to initiate the quotation process. They will be able to answer your questions in the first instance, and we recommend you use the free material:

BSI has a dedicated resource for your MDR Transition
Listen to one of our free webinars or read through the BSI whitepapers

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