2017 Enews

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2017 Enews

2017 enews

MDR and IVDR Critical Update >

BSI has submitted designation applications for the Medical Devices Regulation and the In Vitro Diagnostic Regulation to both the UK and The Netherlands Competent Authorities.

BSI Medical Devices Brexit Update 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.

New Medical Devices Regulation and IVD Regulation text published >

The final texts of the new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have been published in the Official Journal of the European Union today. The Regulations will enter into force on May 26th, marking the start of the transition period for manufacturers selling medical devices into Europe.

BSI opening a second EU Notified Body based in the Netherlands >

BSI continues with it's plan to open a second Notified Body based in the Netherlands. Following the application made in February, next steps are a Joint Assessment of BSI by EU Competent Authorities and European Commission representatives later this year.

EU referendum result >

BSI’s role as an EU Notified Body will not change following the recent UK decision to leave the European Union.

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2017 Enews