BSI achieves Designation for its Netherlands Medical Devices Notified Body
13 November 2018
BSI, the leading UK based EU Medical Devices Notified Body is pleased to announce that after successful applications in the Netherlands to the Dutch Ministry of Health and European Commission it has now achieved full designation as a Medical Device Notified Body in the Netherlands for the following EU directives:
- Active implantable medical devices (90/385/EEC)
- Medical devices (93/42/EEC)
- In vitro diagnostic medical devices (98/79/EC)
BSI in conjunction with the Netherlands and UK Competent Authorities has agreed a pragmatic process for operating across the two Notified Bodies. BSI’s strategy is to continue and grow two EU Medical Device Notified Bodies in the two geographies. However, in a scenario where a manufacturer has made the business decision to move their UK certificates to the Netherlands Notified Body, there is a straightforward process which is primarily administrative to migrate existing CE certificates to the new Netherlands Notified Body. This process does not require formal conformity assessment.
As information will be openly shared between the two BSI Notified Bodies full traceability and linkages to the current certificates will be maintained. Product labelling will need to be updated to reflect the new Notified Body number. However, BSI anticipates that due to continued traceability, the short timelines usually associated with a Notified Body transfer will not apply as this is considered as a migration activity between the two BSI Notified Bodies. This will allow clients to change their labelling during their normal product lifecycle plans, as new products are introduced or during the change to the new Regulations.
Gary Slack, Senior Vice-President of Medical Devices at BSI said: “BSI is very pleased to be in the position where we can now further develop and secure BSI’s EU Notified Body activity in mainland Europe and continue building a significant presence working out of our already active Amsterdam office.”
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