As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – New Notified Body designated to IVD Directive in Europe

An interesting fact was overlooked in the headlines last year: Since November 5, 2021 a new Notified Body has been designated for the In-Vitro...
With 6 months until new EU medical device rules, what's the state of play?

Europe – IVDR: European Commission publishes second batch of harmonized standards

On Thursday, the European Commission officially recognized five additional harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices...

Europe – European Commission publishes second batch of harmonized standards under MDR

The European Commission on Tuesday officially recognized nine harmonized standards for medical devices that device makers can reference in order to satisfy conformity requirements...

Europe – Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the coordinated assessment pathway it is piloting to streamline the review...
Double peine pour la medtech suisse

Switzerland – Medical device direct imports to users in Switzerland

The concept of “importation” can be seen from various perspectives. Someone may physically transport a product across a border, which is addressed from a logistics...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – The past, the present, and the future of clinical trials transparency in...

The UK has been leading the way in supporting and promoting transparency of clinical trials. Following our exit from the EU, the MHRA has...

Europe – EU IVDR Readiness Assessment Checklist

Is your company ready for the implementation of the European In Vitro Diagnostics Regulation (IVDR)? Under the IVDR, in vitro diagnostic (IVD) device CE Marking...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – European IVDR application partially postponed

On December 15, 2021, the European Parliament voted by an overwhelming majority (687 to 6) to adopt proposals by the European Commission to delay...

Europe – Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation

The In Vitro Diagnostic Medical Devices Regulation that will apply as from 26 May 2022, can now be progressively rolled out, thanks to its adoption by the...

Europe – Annex XIV of the European MDR and clinical development plans for medical...

Annex XIV of the Medical Devices Regulation (EU) 2017/745 (MDR), section 1(a), 8th indent, requires a Clinical Development Plan (CDP). Some manufacturers may need more...

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