2021 Medical Device News MDR, IVDR, BREXIT

Latest news updates

24 November 2021

European Commission proposal for IVDR transition timelines >

On 14 October 2021, The European Commission proposed to amend the transition period of devices covered by the In Vitro Diagnostic Regulation (IVDR) 2017/746.

30 September 2021

Missed agreed submission date for technical documentation >

BSI works to ensure we schedule your technical documentation review around your current product lifecycle strategy, as noted in your completed Device Schedule.

30 August 2021

Launch of digital pre-application portal >

We are delighted to announce that all our digital pre-applications for CE marking, UKCA and QMS services are now online and form part of our pre-application portal.

24 June 2021

Minimum MDR/IVDR capped QMS audit durations >

BSI has been delivering In Vitro Diagnostic (IVDR) and Medical Device Regulation (MDR) quality management system (QMS) audits for over a year. Our operational teams have been gathering feedback on the processes and timelines.

10 June 2021

Devices covered by AIMDD/MDD certificates from 26 May 2021 >

The MDR EU 2017/745 came into effect on 26 May 2021. Article 120 of the MDR has specific transitional provisions in relation to devices that continue to be placed on the market under AIMDD 90/385/EEC or the MDD 93/42/EEC and for certificates issued under those legislation.

23 June 2021

BSI statement on conformity assessment for class D devices under the IVD Regulation >

BSI would like to draw your attention to an important update regarding notified body activity for Class D IVDs under the In Vitro Diagnostic Regulation (IVDR) EU 2017/746.

26 May 2021

Preparing your submission for the Expert Panels of the European Commission >

On 1 April 2021, the European Commission (EC) launched its Expert Panels to provide consultation in relation to activities defined in Article 54 of the Medical Devices Regulation (MDR EU 2017/745), also known as the Clinical Evaluation Consultation Procedure (CECP).

11 May 2021

ISO 13485 following Brexit >

ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices under European Directives and Regulations and UKCA marking medical devices under the UK MDR 2002.

21 April 2021

Manufacturers and EU Authorized Representatives in Switzerland >

Switzerland and the EU have been in discussions about the future agreement between the two geographies related to medical devices and several other product types.

29 April 2021

Technical Documentation IVDR/MDR timelines >

BSI is currently working in unprecedented circumstances, with increased requirements and a positive stream of applications for EU In Vitro Diagnostic Regulation (IVDR) and EU Medical Device Regulation (MDR).

03 February 2021

BSI certifies first AIMD product to the MDR >

BSI today announced that it has certified its first Active Implantable Medical Device (AIMD) products to the Medical Devices Regulation (MDR) (EU 2017/745) via its Notified Body in The Netherlands (2797).

29 January 2021

BSI issues the first UKCA certificate >

BSI today announces that it has issued its first UKCA certificate under the UK MDR 2002 legislation for medical devices via its newly designated UK Approved Body (0086). The first UKCA certificate covers theatre instrument sets.

14 January 2021

BSI notified body 2797 remote audits update >

Read BSI's statement in relation to the Commission Notice (2021/C 8/01) published on 8 January 2021 relating to MDR (EU) 2017/745 and IVDR (EU) 2017/746 audits undertaken during the current acute COVID-19 pandemic restrictions.

06 January 2021

BSI issues its first certificate to the In Vitro Diagnostic Devices Regulation >

BSI announced on 18 December 2020 that it has certified its first group of products to the In Vitro Diagnostic Devices Regulation (IVDR) EU 2017/746 via its Netherlands Notified Body (2797).