August 28, 2023

EUDAMED Update: New Mid-2025 Implementation Date?

It appears EUDAMED will be postponed to mid-2025. Read why and the potential new deadlines here, including links to the Working Group's recent meeting minutes.
August 23, 2023

MDCG Decision Flowcharts: Legacy Devices & Class III Custom-made Implantables

The MDCG published flowcharts for legacy devices & Class III custom-made implantables. It helps determine if a device is covered by Regulation 2023/607 or not.
August 15, 2023

Team NB Updates: Capacity, Bottlenecks & Transfer Agreement Template

Team Notified Body (NB) issued a Position Paper on their current capacity & expected bottlenecks, and a Transfer Agreement Template for legacy devices.
July 25, 2023

EU Commission Updated Survey: MDR/IVDR Certificates & Applications

The EU Commission published an updated survey: Notified Body MDR/IVDR Certificates & Applications. Find out the current stats; as well, why this is important to you.
July 18, 2023

MDR Extension Q&A Updated, Plus Link to New Manufacturer Template

The EU Commission updated the MDR Transition Extension (2023/607) Q&A. It includes a new manufacturer template and newly answered questions. Read the update.
July 10, 2023

List of MDR & IVDR Harmonized Standards Updated

The list of Harmonized Standards under the MDR and IVDR has been updated. Click here to find out what was added and what was modified.
June 30, 2023

MDCG Issues Addendum to Guidance Document MDCG 2022-18

The MDCG released an addendum to clarify the purpose of the guidance document 2022-18, and that its use is no longer applicable.
June 21, 2023

New IVDR Common Specifications Expected Q4 2023

The EU Commission announced it will soon release new Common Specifications for Class D IVD devices. Find out which products and the target release date.
June 19, 2023

2023 Mid-Year Regulatory Updates: EU, UK, and Switzerland

Find out the major regulatory changes of the 1st half of 2023, and expected changes for the remainder of the year in Europe, the UK and Switzerland.