2019 Medical device news and industry updates

Latest news updates

24 12월 2019

BSI designated to the In Vitro Diagnostics Regulation in the Netherlands >

BSI was informed on 24th December 2019 by the Dutch Ministry of Health (VWS) that its Netherland’s notified body has been designated to the new IVDR (EU 2017/746)1. BSI will now be able to provide conformity assessments to the full scope of the IVDR which includes over 80 codes.

06 11월 2019

BSI achieves designation to the Medical Device Regulation for its Netherlands notified body >

Following on from being the first EU notified body in the world to achieve designation to the Medical Devices Regulation, BSI was informed on 6 November by the Dutch Ministry of Health (VWS) that it’s Netherlands notified body is also now designated to the new MDR (EU 2017/745).

28 10월 2019

BSI achieves designation to the In Vitro Diagnostics Regulation in the UK >

BSI was informed on 26 October 2019 by the Medicines and Healthcare products and Regulatory Agency (MHRA) that it’s UK notified body is one of the first in Europe to be designated to the new IVDR (EU 2017/746).

02 9월 2019

BSI certifies first product to the Medical Devices Regulation >

BSI is delighted to announce that we have certified the first product to the Medical Devices Regulation (MDR) via our UK notified body (0086).

22 8월 2019

Urgent: Class Ir – reusable surgical instruments with a deadline of May 2020 requiring MDR certification >

There are several devices that are available on the market that do not require a CE certificate from a Notified Body under the current Medical Device Directive (MDD). Some of these, however, will require Notified Body certification under the Medical Device Regulation (MDR) by the 26 May 2020 date of application. Class I reusable surgical instruments fall into this category.

16 8월 2019

BSI Service update MDR update, Phthalates, eVigilance and Implant cards >

We are proud to have started our first reviews to the Medical Device Regulation (MDR), and we are putting our processes and procedures to test. It is a very exciting time for the implementation of the MDR. We want to provide you with critical updates to requirements under the MDR so please read this communication with care.

11 7월 2019

ISO 13485 and products with May 2020 deadline for MDR certification >

BSI is now accepting applications under the MDR for our UK Notified Body (0086). Read on to understand the critical information for your business in relation to ISO 13485, certification under MDR and BSI Terms and Conditions of contract.

06 2월 2019

Clarification around UKAS ISO 13485 and no-deal Brexit >

Current BSI ISO 13485 certificates do not need to be transferred to an EU-27 conformity assessment body; they are issued by BSI which is accredited by the accreditation body United Kingdom Accreditation Service (UKAS) or Standards Council of Canada (SCC).

28 1월 2019