Medical Device news center

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 update with the latest news and announcements for medical devices through our enews updates.

Latest news updates

August 11 2023

Suzanne Halliday 2023 RAPS Fellow >

We are delighted to announce that BSI’s VP Regulatory, Suzanne Halliday, has been announced as a fellow of the Regulatory Affairs Professional Society (RAPS).

July 07 2023

BSI issues 1000th MDR certificate >

BSI has achieved a significant milestone by issuing its 1000th Medical Devices Regulation (MDR) Certificate.

July 12 2023

BSI awarded ISO 13485 accreditation by SAC >

From 1 January 2025, only ISO 13485 issued by SAC accredited Certification Bodies will be accepted for Medical Devices license applications in Singapore.

June 07 2023

UKCA extension >

On April 27th 2023, the MHRA officially announced acceptance of Amending Regulation (EU) 2023/607 and an additional twelve-month extension to the current standstill period.

May 25 2023

Sterile medical devices >

BSI announces new scope designation to include non-standard sterilization modalities for sterile medical devices

May 15 2023

Article 86 of EU MDR 2017/745 requires manufacturers of Class IIa, IIb and Class III devices to generate a PSUR and Article 81 of EU IVDR 2017/746 requires manufacturers of Class C and D devices to generate a PSUR.

May 10 2023

BSI issues certificate for IVD Companion Diagnostic (CDx) device >

Full scope Notified Body BSI The Netherlands (2797) is pleased to announce the issue of its first CDx certificate under the In Vitro Diagnostics Regulation (IVDR (EU) 2017/746).

March 20 2023

MDR Transition Timelines Extended >

On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect.

March 20 2023

IVDR amendments and Policy regarding Class D IVDs >

The sell-off provisions specified in IVDR Article 110.4 have been abolished to allow legacy IVD medical devices already placed on the market under the Directives to be made further available without an end date.

January 30 2023

ISO 13485 changes to audit durations >

As a company certified by BSI Group pursuant to the requirements of ISO 13485, and we would like to inform you of the following change to audit durations.