MDCG 2024-3: New Guidance on Clinical Investigation Plan Contents & Synopsis Template
New MDCG guidance Clinical Investigation Plan contents has been issued. Plus, a Word version Clinical Investigation Plan Synopsis Template. Click ...
Switzerland-EU Mutual Recognition: New Negotiation Discussions Underway
This month the Swiss Federal Council and EU Commission will resume formal negotiations; if successful, this will restore mutual recognition ...
New EU MDR/IVDR Harmonized Standards Published
Eight new standards have been harmonized under the EU MDR and three newly harmonized under the EU IVDR. Click here ...
Team Notified Body: New MDR Training (June) and Upcoming Webinar (March)
Team NB has announced a 6th MDR training session for June 2024. The April 2024 training is now fully booked. ...
Team NB Position Paper: Proposal to Reclassify SARS-CoV-2 (COVID) in vitro Diagnostic Devices
Team Notified Body has proposed reclassifying SARS-CoV-2 (COVID) IVD devices. Find out the proposed new classification and consequences for manufacturers.
New Association Formed in the UK: Team Approved Body (“Team AB”)
Like Team Notified Body, there is now an association for UK Approved Bodies (“Team AB”). Find out their goals, plus ...
‘swissdamed’ Registration Database: Launch date pushed to 2nd Half 2024
Swissdamed is being postponed, due to continued on work on the IT infrastructure. Find out the new 'go-live' dates and ...
MDCG 2024-2: Process & Timing to Add, Amend, Obsolete New EMDN Codes
MDCG 2024-2 outlines the process of reviewing new EMDN code requests. Find out how they are processed, the timing, and ...
MDR Transition Deadline of 26 May 2024: What is a “lodged” application with the Notified Body?
By May 26, 2024 MDD/AIMDD devices must have ‘lodged an application’ with a Notified Body, or they lose access to ...
Team Notified Body: New MDR Training Session Available for April 2024
Team Notified Body has scheduled another MDR training session for Monday, 29 April 2024. Click here for the agenda, fees, ...
New: MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Templates
The MDCG issued guidance harmonizing vigilance reporting for serious incidents, Periodic Summary Reports, and trend reporting. Click here for the ...
MHRA Adds Two New UK Approved Bodies: LNE-GMED UK Limited & Scarlet NB UK Ltd
The MHRA newly designated LNE-GMED & Scarlet NB as UK Approved Bodies. Find the list of all Approved Bodies, their ...
New Commission Proposal: Further Delay to IVDR, New Reporting Obligation & New EUDAMED Deadline
New Commission Proposal to 1) further the delay the IVDR for 'legacy' devices 2) require manufacturers to report disruption to ...
EU Commission Publishes Language Translation Requirements under the MDR & IVDR
New EU Commission resource: consolidated Language Translation Requirements under the MDR/IVDR. Find out what’s included, what’s excluded, and get the ...
UK MHRA: 2024-2025 Roadmap of Future Regulatory Framework
The UK MHRA updated the timing and planning for the new medical device and IVD regulation. Click here for the ...
EU Commission: New Dashboard Monitoring Availability of Medical Devices on the EU Market
The European Commission created a new dashboard, providing an overview of the availability of medical devices & IVDs on the ...
MDCG 2023-7: Clinical Investigation Exemptions & Claiming Equivalence
MDCG 2023-7 on clinical investigation exemptions & level of data needed to claim equivalence, was newly published in December 2023. ...
MDCG 2019-07 Updated: MDR/IVDR Art. 15, Person Responsible for Regulatory Compliance (PRRC)
MDCG 2019-07, on the Person Responsible for Regulatory Compliance (PRRC), was originally published in June 2019. It has now been ...
MDCG 2021-27 Updated: Q&A on MDR/IVDR Articles 13 (Importers) & 14 (Distributors)
MDCG 2021-27 has been revised to add six new Q&As and update three existing Q&As. For the link and what's ...
Team Notified Body (NB) Position Paper: Medical Device Lifetime
Team NB released a new position paper on medical device lifetime: common understanding of the term, how to determine lifetime ...
MDCG 2021-6 Updated: MDR Q&A Regarding Clinical Investigations
A revision to MDCG 2021-6, MDR Q&A regarding clinical investigations, has been released. Click here to access the link and ...
Five EU Reference Laboratories (EURLs) Designated for Class D IVDs
On 5 December 2023, the EU Commission designated 5 new EURLs. Read here for the implementation date, list of EURLs ...
EU Commission asks Manufacturers & EU ARs to participate in MDR/IVDR transition survey
The EU Commission asks manufacturers and EU ARs to participate in their survey regarding availability of medical devices in the ...
Team Notified Body: New IVDR Training Session
Team Notified Body (NB) has scheduled a third IVDR training session for Thursday, February 1, 2024. Find out the agenda, ...
Team NB Training Survey Results & EU Competent Authorities ‘MDR Call to Action’
Team Notified Body issued a press release re: its first MDR training for manufacturers. The Competent Authority for Medical Devices ...
Team NB: New MDR Training Sessions Added for February/March 2024
Team Notified Body (NB) has scheduled a third MDR training session for Wednesday, February 7, 2024. Find out the agenda, ...
Swiss Federal Council: Drafting New Negotiating Mandate to Remain in the EU Single Market
The Swiss Federal Council is drafting a new EU negotiating mandate. If accepted, it would put Switzerland fully back into ...
EU Delegated Regulation 2023/2197 Published: “Master UDI-DI” for “highly individualised devices”
The EU Commission published Delegated Regulation 2023/2197 on ‘Master UDI-DI’ for contact lenses. What does this mean and how does ...
MDCG 2023-4: Guidance on Medical Device Software – Hardware Combinations
The Medical Device Coordination Group released MDCG 2023-4 on Medical Device Software (MDSW) – Hardware combinations. Click here for the ...
Commission Publishes New EUDAMED Timeline: Delayed Until at Least 2027
The EU Commission published a new draft EUDAMED timeline on its website. It is now delayed until at least Q2 ...