Regulatory Changes throughout the year to keep you up to date

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

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

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

BSI certifies first product to the Medical Devices Regulation >

BSI, today announces that it has certified the first product, the Novartis Concept1 inhaler, to the medical devices regulation (EU 2017/745) via its UK notified body (0086). The Novartis Concept1 inhaler is classified as a IIa device under Rule 20 for the MDR. Prior to the new more stringent legislation coming into force, the inhaler was classified as a Class I device and did not need to be reviewed by a notified body.

Urgent: Class Ir reusable surgical instruments >

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.

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

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

BSI announced in January 2019 that BSI UK was the first EU Notified Body (NB) to achieve designation, under the Medicines and Healthcare products Regulatory Agency (MHRA) to the Medical Device Regulation (MDR) (EU 2017/745). We are now accepting applications under the MDR for our UK Notified Body (0086).

Urgent BREXIT Implications for Market Access - less than 60 Days Out from 29 March 2019 >

We are approaching the Article 50 BREXIT deadline and are now less than 60 days away from a potential hard Brexit; the 29 March 2019. When BSI initiated our NL contingency plan in August 2016, we could not have foreseen the lack of political progress. Given the current political impasse and following requested updates in the last week from both Competent Authorities for BSI, we have obtained critical information from IGJ /VWS in the Netherlands and the UK MHRA. We would like to provide a clear update to you on our discussions.

BSI first EU notified body to achieve designation to the Medical Device Regulation >

This new regulation was published on 5 May 2017 and manufacturers will need to start complying with it by the 26 May 2020 in order to be able to place their devices on the market within the European Economic Area. The challenge, until now, has been that no notified body was approved to undertake conformity assessments under the new, more stringent, legislation.

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