New Template Available: Notified Body Transfer Agreement for Surveillance of IVDD Legacy Devices
Team Notified Body published a new Transfer Agreement template, on taking over surveillance activities for IVDD legacy devices. Click here ...
UK Registration: Did you update your expired MDD / AIMDD CE Certificate with the MHRA?
The MHRA recognizes the EU MDR transition extension for MDD/AIMDD devices. However, they required an extra step be completed by ...
IMDRF Update: List of Countries That Have Implemented IMDRF Guidance Documents
The IMDRF published an ‘Implementation Report’, outlining which countries have fully, partially, or not implemented IMDRF technical documents into their ...
August Round-up: UK MHRA Proposal to Increase Fees, Update on GMDN to EMDN Mapping, and More
An overview of the MHRA's new proposal to increase fees, plus other August news items that were not individually reported.
EU Commission Publishes Draft of New IVDR Common Specifications for Public Feedback
The EC is proposing to add new Class D common specifications to Implementing Regulation (EU) 2022/1107. Click here for the ...
Switzerland to Recognize Extended IVDR Transition Period under EU Regulation 2024/1860
Switzerland announced it will implement the extended IVDR transition period for legacy devices, granted under EU Regulation 2024/1860. Read here ...
EU Commission: Publishes Links to Each Notified Body’s List of Public Fees
The Commission published a consolidated list of each Notified Body's public fee schedule. Click here for the link; plus, how ...
EU Commission: New Survey to Collect Feedback from Professional Users on eIFUs for Medical Devices
The Commission launched a survey on potentially allowing eIFUs for all professional use medical devices. It's targeted to healthcare professionals ...
Newly Available: Notified Body IVDR Transition Extension Letter Template
A Notified Body confirmation letter template has been released, for the IVDR extension under Reg 2024/1860. Click here for the ...
New Template Available: IVDR Transition Compliance Statement for IVDD Legacy Device Manufacturers
MedTech Europe published an IVDR extension compliance Declaration template for IVD legacy device manufacturers. It is free and downloadable as ...
EU Commission Publishes New IVDR Transition Extension Q&A and Updates to MDR Transition Q&A
The EU Commission published a Q&A document on the ‘practical aspects’ of the IVDR extended transition period, newly granted under ...
EU Commission Publishes Updated Draft EUDAMED Timeline
Following the formal publication of the gradual EUDAMED rollout, the EU Commission has released an updated draft timeline for EUDAMED ...
MDCG 2020-16 Rev.3: Updated IVD Classification Guidance Document
The MDCG published a new revision (Rev.3) to Guidance 2020-16 - IVDR classification rules, on 8 July 2024. It is ...
Regulation 2024/1860 Published: IVDR Extension, EUDAMED Rollout & Reporting Device Shortages
EU Commission published amending regulation to extend the IVDR transition period, rollout EUDAMED in stages, and require reporting of supply ...
Team Notified Body: Transfer Agreement for Surveillance of MDD/AIMDD Legacy Devices Updated
Team Notified Body released a new version (v2) of the Transfer Agreement, on taking over surveillance activities for legacy devices. ...
Team Notified Body: New MDR Training Session Available November 6, 2024
Team Notified Body has scheduled another MDR training session for Wednesday November 6, 2024. Click here for the agenda, fees, ...
Device Supply Disruption: Updated Reporting Process in France starting September 1, 2024
French Competent Authority (ANSM) has updated the process to report on potential device supply disruptions in France, starting on September ...
IMDRF Table of Contents, Plus June Round-up of Various EU MDCG Guidance
Find here an overview of the new IMDRF Table of Contents (ToCs) and the June EU guidance documents, including MDCG ...
Switzerland ‘swissdamed’ Actor Registration Module: Go-live Scheduled for August 2024
The new ‘go-live’ date for the swissdamed Actor registration module is August 6, 2024. Find out how this impacts you; ...
MDCG Work Items: Status on Planned and Ongoing Deliverables for 2024
Each year the MDCG releases an updated list of ongoing work deliverables. Find out here the progress on the full ...
GMDN Agency: Training and Q&A Workshops Scheduled for Manufacturers and Regulators
The GMDN Agency is hosting an online training session for manufacturers on Thursday 27 June 2024. Click here for the ...
EU Harmonized Standards: Updated List of Standards to be Revised and Newly Created
The list of pending EU harmonized standards was newly updated. The CEN and Cenelec have been requested to revise and ...
Progress Update: Commission Proposal to Extend the IVDR Transition Period & Rollout EUDAMED
The EU Commission’s proposal is making its way through the legislative process. Read about the most recent update on its ...
MDCG 2022-4 Rev. 2: Updated due to extended MDR transition period & EUDAMED rollout
MDCG 2022-4 on MDR Appropriate Surveillance has been updated due to the extended MDR transition period, and eventual EUDAMED rollout. ...
UK MHRA Updates: Draft Policy for International Recognition Framework & New IVD Consultation
The MHRA published a draft of its new international recognition framework policy. Find out which countries are included, the eligibility ...
EU Commission Survey: Notified Body Update on MDR/IVDR Certifications & Applications
The EU Commission published an update on the status of MDR/IVDR progress, as reported by the Notified Bodies. It is ...
MDCG Presentations from April “Extraordinary” Meeting & Team Notified Body Internal Survey
Find here the presentations from the MDCG’s April meeting, including from the Competent Authority Task Force on device shortages. Plus, ...
New IMDRF Guidance: Labelling, Safety & Performance, Regulatory Review Reports and more
The IMDRF released new guidance on labeling, safety & performance requirements, regulatory review reports, and more. Click here for the ...
MHRA to Small-to-Medium Companies: Volunteer to Help Test UK International Recognition Framework
The MHRA is asking small-to-medium sized manufacturers for help testing the new UK International Recognition Framework. The deadline to volunteer ...
EU Updates: MDCG Meeting on Device Shortages due to the May MDR Cutoff & New MDR/IVDR Industry Survey
The MDCG called a special meeting to discuss the May 26, 2024 deadline, including how to handle device shortages. Plus, ...