BSI Medical Devices Brexit Update November 2017

Enews – 10th November 2017

Following the triggering of Article 50, BSI will continue to help organizations achieve their goals as we have done for the past 116 years. For BSI it is business as usual, BSI expects to remain a full member and influential participant in the single European Standards system as well as an EU Notified Body. BSI will continue to play an important role in helping both British and overseas Manufacturers demonstrate product conformity.

BSI strengthening European links

Our intention is to further develop and secure BSI’s EU Notified Body activity in mainland Europe and continue building to establish a significant presence in the Netherlands over the next two years. This presence will focus upon the existing BSI Netherlands headquarters in Amsterdam.

  • Product Certification: BSI has formally applied for designation as a Medical device Notified Body in the Netherlands under the EU Directives; (90/385/EEC) Active implantable medical devices, (93/42/EEC Medical devices) and (98/79/EC) IVD directive within the oversight of the Dutch Health and Youth Care Inspectorate (IGJ). IGJ have completed our initial Audit and we are working through the process of designation.
  • ISO 13485: BSI has applied for Accreditation under the Dutch Accreditation Council (RVA) and we have received our initial assessments. The RVA accredits management system certification bodies based on the ISO/IEC 17021 standard.

Ongoing Communications

As Brexit negotiations progress and our discussions with the UK government and other relevant authorities evolve, we will continue to keep you informed on progress on both this page and via other communications. BSI will be working closely with the Medicines and Healthcare Products Regulatory Agency (MHRA), UK Department of Health, to ensure continuity of our full scope designation as a UK based EU Notified Body for Medical Devices.  In parallel adding the Netherlands EU Notified Body designation with IGJ.

BSI has created a Brexit homepage for you to find all the latest information.

To read this communication in another language please click on a link below: