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[Blog] Medical Devices access to UK market after the Brexit

Currently, the UK is a participant in the European regulatory network for medical devices, but after the end of the transition period, this participation will also end.  The Medicines and Healthcare products Regulatory Agency will take on the responsibilities for the UK market undertaken through...

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[Whitepaper] Frequently Asked Questions About Medical Devices

The EU's Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). In this whitepaper, you...

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[Glossary] EU MDR and IVDR: The core terms you should know

[Glossary] EU MDR and IVDR: The core terms you should know

The European Union (EU) is approaching its deadline to implement the Medical Device Regulation (EU MDR). As the transition period ends on May 26, 2020, a wider and clearer regulatory scope for medical devices is just around the corner. The EU MDR establishes requirements for manufacturers...

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