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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
MDCG 2023-3: Q&A on MDR Vigilance Terms and Concepts
European Union

MDCG 2023-3: Q&A on MDR Vigilance Terms and Concepts

New MDCG guidance was issued on MDR vigilance terms & concepts. Find out the key takeaways, including when the reporting ...

February 14, 2023
New UK MHRA Fees Starting April 2023
United Kingdom

New UK MHRA Fees Starting April 2023

Today the MHRA announced increased application fees, starting April 2023. Click here to find out the new medical device registration, ...

January 31, 2023
EU Council Accepts Proposal to Postpone MDR Deadline
European Union

EU Council Accepts Proposal to Postpone MDR Deadline

The EU Council has officially accepted the proposal, with no changes. What does this mean in terms of timing to ...

January 31, 2023
MDCG 2023-2: Guidance on Publishing Notified Body Fees
European Union

MDCG 2023-2: Guidance on Publishing Notified Body Fees

The MDCG published a guidance document on Notified Body fee transparency, including a table of how fees could be presented ...

January 12, 2023
Swissmedic Implements MDCG 2022-18 to Deal with MDR Certification Gaps
Switzerland

Swissmedic Implements MDCG 2022-18 to Deal with MDR Certification Gaps

Switzerland announced it will implement MDCG 2022-18, to deal with MDR certification gaps under MDR Article 97. Find out the ...

January 12, 2023
EU Commission Releases Official Proposal to Extend the MDR Transition Period
European Union

EU Commission Releases Official Proposal to Extend the MDR Transition Period

Today the EU Commission published its official proposal to extend the transition period for MDR legacy devices. Click to find ...

January 6, 2023
United Kingdom

United Kingdom: 2022 Recap & 2023 Look Forward

Find out what regulatory news you may have missed from the MHRA in 2022, and to see the upcoming 2023 ...

January 4, 2023
European Union

Europe: 2022 Recap & 2023 Look Forward

Find out what regulatory news you may have missed from the EU Commission and MDCG in 2022 and the upcoming ...

January 4, 2023
Switzerland

Switzerland: 2022 Recap & 2023 Look Forward

Find out what regulatory news you may have missed from Swissmedic in 2022, and the upcoming 2023 deadlines for medical ...

January 4, 2023
MDCG 2022-4 Rev. 1 Update Released: What Has Changed & Why?
European Union

MDCG 2022-4 Rev. 1 Update Released: What Has Changed & Why?

MDCG 2022-4, originally published in February 2022, has been updated December 2022. Find out why it was revised, what has ...

December 20, 2022
MDCG 2022-21: Guidance on Periodic Safety Update Reports (PSURs)
European Union

MDCG 2022-21: Guidance on Periodic Safety Update Reports (PSURs)

The MDCG released guidance on Periodic Safety Update Reports (PSUR). Read our overview of who needs one, how to comply ...

December 20, 2022
MDCG 2022-18: Guidance for MDD/AIMDD Manufacturers with Expiring Certificates
European Union

MDCG 2022-18: Guidance for MDD/AIMDD Manufacturers with Expiring Certificates

The MDCG published new guidance on how to market under MDR Article 97, after an MDD/AIMMD CE certificate expires. Find ...

December 9, 2022
Breaking: EU Council Supports Postponement of the May 2024 MDR Deadline
European Union

Breaking: EU Council Supports Postponement of the May 2024 MDR Deadline

The EU Council confirmed they will present a legislative amendment in early 2023 to postpone the May 2024 MDR deadline, ...

December 9, 2022
MHRA Guidance: Use of Logo and Registration ‘Endorsement’ Claims
United Kingdom

MHRA Guidance: Use of Logo and Registration ‘Endorsement’ Claims

The MHRA updated its Medical Device Registration guidance to confirm that companies may not use their logo or make certain ...

December 6, 2022
European Union

EU MDCG 2022-17 Guidance on ‘Hybrid Audits’

The MDCG released a new position paper on 'hybrid audits'. Click here to read the definition and to which situations ...

December 6, 2022
Switzerland

Class D IVD Deadline to Appoint Swiss Authorized Rep: 31 Dec 2022

Manufacturers of Class D IVDs must appoint a Swiss Authorized Representative by 31 December 2022. This is required even if ...

December 1, 2022
Swiss Parliament Votes to Accept US FDA Devices
Switzerland

Swiss Parliament Votes to Accept US FDA Devices

Today Swiss Parliament voted to allow FDA approved devices onto the Switzerland market, in addition to European CE marked devices. ...

November 28, 2022
Swissmedic Seminar on IvDO/IVDR
Switzerland

Swissmedic Seminar on IvDO/IVDR

Swissmedic hosted a seminar on the new IVD Ordinance in Switzerland. Read about the current situation with Europe, the IVDR, ...

November 18, 2022
New MDCG Guidance 2022-16 on Authorized Representatives
European Union

New MDCG Guidance 2022-16 on Authorized Representatives

The MDCG released a new guidance document on EU Authorized Representatives (ARs). Find out the contractual obligations between Manufacturers and ...

November 11, 2022
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