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Current Status: Swiss Acceptance of US FDA Devices
Switzerland

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 ...

August 31, 2023
Three New UK Approved Bodies Available for UKCA Marking
United Kingdom

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 ...

August 29, 2023
EUDAMED Update: New Mid-2025 Implementation Date?
European Union

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 ...

August 28, 2023
MDCG Decision Flowcharts: Legacy Devices & Class III Custom-made Implantables
European Union

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 ...

August 23, 2023
European Union

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 ...

August 15, 2023
Swissdamed Registration Database: 2023-2024 Release Dates Confirmed & Sneak Peek
Switzerland

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 ...

August 10, 2023
UK MHRA Clarifies CE Marking Timeframes for Medical Devices & IVDs
United Kingdom

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 ...

August 1, 2023
UK MHRA Post-Market Surveillance: Draft Legislation Released
United Kingdom

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 ...

July 27, 2023
EU Commission Updated Survey: MDR/IVDR Certificates & Applications
European Union

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, ...

July 25, 2023
MDR Extension Q&A Updated, Plus Link to New Manufacturer Template
European Union

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. ...

July 18, 2023
New MHRA Guidance: Marketing IVDs in Great Britain
United Kingdom

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 ...

July 17, 2023
List of MDR & IVDR Harmonized Standards Updated
European Union

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 ...

July 10, 2023
UK MHRA: Update on Plan to Recognize Approvals from “Trusted Regulators”
United Kingdom

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. ...

July 4, 2023
MDCG Issues Addendum to Guidance Document MDCG 2022-18
European Union

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 ...

June 30, 2023
European Union

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 ...

June 21, 2023
European Union

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 ...

June 19, 2023
MDCG 2020-3 Rev. 1: Updates to MDR Signifcant Changes Guidance
European Union

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 ...

May 16, 2023
Team Notified Body Issues MDR Transition Extension Letter Template
European Union

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 ...

May 8, 2023
UK MHRA Announcement: New Dates for UK Regulation & CE Marking
United Kingdom

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 ...

April 27, 2023
Swissmedic Confirms It Will Recognize EU MDR Transition Extension
Switzerland

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 ...

March 30, 2023
UK MHRA to Recognize MDR Transition Extension in Great Britain
United Kingdom

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. ...

March 28, 2023
EU Commission Publishes Q&A on the MDR Transition Extension
European Union

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 ...

March 24, 2023
New EU Commission Proposal: “Master UDI-DI” for “highly individualised devices”
European Union

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 ...

March 23, 2023
MDR Extension Published, Enters into Force Today
European Union

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 ...

March 20, 2023
MDCG: 2023 Guidance Documents in Development
European Union

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 ...

March 10, 2023
UK Future Plans: International Agency Recognition, Innovation Routes & Capacity
United Kingdom

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) ...

March 7, 2023
EU Council Adopts MDR Extension: What’s Next?
European Union

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 ...

March 7, 2023
Switzerland

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 ...

March 1, 2023
MHRA Statement: Impact of the EU Commission’s MDR Extension in the UK
United Kingdom

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 ...

February 20, 2023
EU Parliament votes “yes” to the MDR Postponement
European Union

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 ...

February 16, 2023
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