24 December 2019
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.
This is the fourth and final designation for BSI and now both its notified bodies – UK and Netherlands - have full scope designation to the In Vitro Diagnostics Regulation and the Medical Devices Regulation.
Gary Slack, Senior Vice-President of the notified body at BSI, said: “Back in June 2016, we made a pledge to our clients to provide seamless, uninterrupted access to the market whatever the outcome of Brexit. We were aware from market data that around one-third of medical devices products placed on the European market were assessed by BSI and if we lost our notified body status it posed a major risk to patient access of these devices. By having fully designated notified bodies in both the UK and Netherlands, we have achieved that promise.”
Manuela Gazzard, Group Director of Regulatory Services at BSI commented: “The teams have worked exceptionally hard to obtain these designations in both markets. Not only have they achieved designation to the new, more stringent regulations but they’ve had to face the challenge of Brexit and create a whole new notified body in the Netherlands. This achievement is testament to the dedication, skill and expertise of our people”
For further details on BSI’s scope, please visit the NANDO information system.
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Notes to Editors:
1 The IVDR was published on 5 May 2017 and manufacturers will need to start complying with it by May 2022 in order to be able to place their devices on the market within the European Economic Area.