2020 Medical device news and industry updates

Latest news updates

10 diciembre 2020

UKCA update 0086 >

Current UK-based EU notified bodies, such as BSI UK 0086, will become UK Approved Bodies (UKAB) and their scope of designations under the EU legislation will automatically roll over on the 1 January 2021. BSI UK will retain its identification number, 0086.

26 octubre 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 octubre 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 octubre 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 setiembre 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 agosto 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 junio 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.

21 abril 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.

16 abril 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.

27 marzo 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 febrero 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.

04 febrero 2020

Post-Brexit update on the validity of CE certificates issued by our UK Notified Body (0086) >

Following the official announcement on Friday 31 January 2020 that the UK has officially ceased to be a member of the European Union, the UK has now entered a transition period in which it will negotiate future business and trade agreements with the EU. What does this mean for medical device manufacturers?

23 enero 2020

Second corrigendum to the MDR and IVDR >

The EU Commission has now published the second corrigenda to the MDR and IVDR; Vigilance Reporting – updated Manufacturer Incident Reporting (MIR) forms in the Official Journal of the EU (OJEU).

17 enero 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.