Current Status: Swiss Acceptance of US FDA Devices
Swiss Parliament approved allowing FDA devices almost one year ago (Nov 2022). What is the progress as of today (Aug ...
Three New UK Approved Bodies Available for UKCA Marking
The MHRA has designated three additional UK Approved Bodies. Click for the link to see the full list of available ...
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 ...
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 ...
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 ...
Swissdamed Registration Database: 2023-2024 Release Dates Confirmed & Sneak Peek
Swissmedic released an update on swissdamed, the medical device registration database. It includes updated 'go-live' dates & user manual. Click ...
UK MHRA Clarifies CE Marking Timeframes for Medical Devices & IVDs
The MHRA clarifies that the UK Department of Business and Trade's announcement regarding "indefinite CE mark recognition" does not apply ...
UK MHRA Post-Market Surveillance: Draft Legislation Released
The draft UK Post-market Surveillance (PMS) Requirements have been published. What are the proposed new PMS requirements & when will ...
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, ...
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. ...
New MHRA Guidance: Marketing IVDs in Great Britain
Today the UK MHRA released a new guidance document on how to market IVD devices in Great Britain. Click here ...
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 ...
UK MHRA: Update on Plan to Recognize Approvals from “Trusted Regulators”
The MHRA released an update on timing to create an equivalency route for “trusted regulators” such as the US FDA. ...
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 ...
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 ...
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 ...
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 ...
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 ...
UK MHRA Announcement: New Dates for UK Regulation & CE Marking
The UK MHRA announced new dates to accept CE Marking & for their Medical Device Regulation. Find out the compliance ...
Swissmedic Confirms It Will Recognize EU MDR Transition Extension
Swissmedic announced today that legacy CE Certificates granted further extension in Europe, will be recognized in Switzerland. Click here for ...
UK MHRA to Recognize MDR Transition Extension in Great Britain
The UK MHRA announced today that legacy CE Certificates granted further extension in Europe, will be recognized in Great Britain. ...
EU Commission Publishes Q&A on the MDR Transition Extension
Now that the MDR transition period has been formally extended, the EU Commission released a Q&A document on the ‘practical ...
New EU Commission Proposal: “Master UDI-DI” for “highly individualised devices”
The EU Commission has proposed a new term and principle (‘Master UDI-DI’) for certain types of medical devices. What does ...
MDR Extension Published, Enters into Force Today
It is now official -- the extension to the MDR transitional provisions has been published in the Official Journal of ...
MDCG: 2023 Guidance Documents in Development
The Medical Device Coordination Group (MDCG) published a (non-exhaustive) list of guidance documents in development for 2023. Click to find ...
UK Future Plans: International Agency Recognition, Innovation Routes & Capacity
The UK government released details regarding international recognition with other regulatory agencies (e.g., US FDA) ...
EU Council Adopts MDR Extension: What’s Next?
Today the EU Council adopted the Commission’s proposal. What are the next steps and when is the MDR extension expected ...
Class B/C IVD Deadline to Appoint Swiss Authorized Rep: 31 Mar 2023
Manufacturers of Class B/C IVDs must appoint a Swiss Authorized Representative by 31 March 2023. This is required even if ...
MHRA Statement: Impact of the EU Commission’s MDR Extension in the UK
The MHRA released a statement today regarding the EU Commission’s intent to extend the MDR transition period. Find out how ...
EU Parliament votes “yes” to the MDR Postponement
Today EU Parliament voted in favor to amend the MDR Article 120 transition provisions, in its first reading. What does ...
