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 ...
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 ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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, ...
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 ...
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 ...
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 ...
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. ...
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, ...
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 ...