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The MDCG released an addendum to clarify the purpose of the guidance document 2022-18, and that its use is no longer applicable.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.
May 16, 2023

MDCG 2020-3 Rev. 1: Updates to MDR Signifcant Changes Guidance

MDCG 2020-3 updated: includes new MDR extension, aligns to MDCG 2022-2, & takes “into account the experience gained with the application of the original version so far”.
May 8, 2023

Team Notified Body Issues MDR Transition Extension Letter Template

Team Notified Body (NB) issued a template letter that can be used to show an expired MDD/AIMDD certificate is still valid. Click here for more details.