23/07/2024 -
New confinis Cybersecurity Services
 
24/05/2024 -
(EU) 2023/607, 26th May 2024 deadline approaching
 
23/05/2024 -
The Future of Health Grant welcomes confinis as a new Program Partner
 
01/05/2024 -
Transitioning to the Medical Device Regulation (MDR) 2017/745
 
11/04/2024 -
Deadline for transitioning to the Medical Device Regulation
 
13/03/2024 -
A Step Forward in Medical Device Manufacturing: the New QMSR Aligned with ISO 13485:2016
 
08/03/2024 -
The EU Artificial Intelligence Act and Medical Device Regulation with Andrea Biasiucci
 
21/02/2024 -
Leveraging Real-World Evidence: Insights and Guidance for Medical Device Manufacturers
 
07/09/2023 -
confinis ag appoints Dario Motti as lead of new Digital Health Competence Cluster
 
03/07/2023 -
Change in Management Structure with Appointment of New CEO at confinis ag
 
02/12/2022 -
The Medical Device Regulation and the medical care for children and rare diseases
 
09/11/2022 -
Working at confinis and the IVDR world with Barbara Jeroncic
 
07/07/2022 -
IVD News – IVDR Date of Application, new Guidance Documents
 
15/06/2022 -
confinis and deep tech with Andrea Biasiucci
 
10/06/2022 -
Electromagnetic Compatibility (EMC) of Medical Devices
 
22/02/2022 -
IVD News – Progressive Roll-Out and MDCG 2022-2 on Clinical Evidence
 
20/12/2021 -
UK Responsible Person Services
 
11/10/2021 -
confinis launches new UK Responsible Person service in UK
 
08/10/2021 -
ISO/FDIS 11608 series opened for voting
 
06/07/2021 -
confinis partners with Irdeto to launch the first cybersecurity assessment tool in the medical devices industry
 
18/06/2021 -
confinis offers Swiss Representative Service
 
26/05/2021 -
Exporting Swiss Medical Devices to the EU
 
24/04/2021 -
Join our Startup Workshop 2021!
 
23/04/2021 -
… and Report your Post-Market Clinical Follow-up Evaluation!
 
10/03/2021 -
How to plan your post-market clinical follow up…
 
18/02/2021 -
How does the notified body assess your clinical evaluation?
 
28/01/2021 -
How to perform a clinical evaluation for Medical Device Software
 
15/01/2021 -
How to ensure sufficient clinical evidence for legacy devices
 
21/12/2020 -
How to claim an equivalence in the clinical evaluation under the MDR
 
10/12/2020 -
Novelties for Clinical Evaluation and Post Market Surveillance within MDR – the Posts Series
 
03/12/2020 -
Bei Medizinprodukten auf die EU warten hilft der Schweiz wenig
 
29/10/2020 -
Clinical and Performance Evaluation – our 5 strengths at your service
 
16/09/2020 -
confinis partners with b-rayZ concerning innovative Artificial Intelligence project
 
02/09/2020 -
Join us at world’s leading AI in medicine summit!
 
14/08/2020 -
Revision der Schweizer Medizinprodukteverordnung mit Folgen
 
13/07/2020 -
Workshop: Software as a Medical Device (SaMD) in Zürich
 
02/06/2020 -
Interpellation Jacqueline de Quattro on medical devices
 
02/06/2020 -
confinis celebrates 15th anniversary
 
13/05/2020 -
Web based tool to analyze effect of significant changes to devices covered by MDD or AIMDD certificates
 
08/05/2020 -
Politics intervene regarding medical devices
 
07/05/2020 -
Development of medical devices to tackle COVID-19 – UPDATE
 
01/05/2020 -
Swiss Medtech Umfrage: Export in die EU mit Drittstaatanforderungen sichern
 
27/04/2020 -
Peter Studer joins confinis as Senior Advisor
 
14/02/2019 -
EU MDR audit requirements and links to MDSAP program
 
27/12/2018 -
From “Essential Requirements” to “General Safety and Performance Requirements” – EU MDR 2017/745
 
20/12/2018 -
Technical Documentation for medical devices under the new European MDR
 
03/12/2018 -
Conformity Assessment Procedures and Premarket Scrutiny under EU MDR
 
12/11/2018 -
Classification of medical devices under the European Medical Device Regulation 2017/745
 
22/10/2018 -
#MDR – Transition periods and definitions
 
22/09/2018 -
Work in progress: MDR implementation – impact on your Quality Management System (ISO 13485:2016)
 
04/09/2018 -
Your insight to: confinis and its partners – work in progress regarding MDR implementation
 
03/09/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 6)
 
03/09/2018 -
From Investigator to Consulting: On the other side of the fence
 
10/07/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 5)
 
29/06/2018 -
WORKSHOP: PMS under the new European MDR
 
26/06/2018 -
“Quick Wins” for your MDR implementation
 
25/06/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 4)
 
19/06/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 3)
 
11/06/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 2)
 
08/06/2018 -
MDR Article 117 – a look into the Crystal Ball (Part 1)
 
03/04/2018 -
confinis opens US office in the Washington DC area
 
06/02/2018 -
MDR Article 117 – are Combination Product Manufacturers prepared?
 
05/01/2018 -
New year, new energy!
 
10/08/2017 -
Beat Steffen to speak at Medtech & Pharma Platform in Basel
 
10/08/2017 -
Upcoming ISO Technical Report regarding Post Market Surveillance
 
15/02/2017 -
Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR): Impact on Switzerland
 

Deadline for transitioning to the Medical Device Regulation

In the rapidly evolving world of medical devices, regulatory transitions can significantly impact product availability and compliance.
Mark your calendars for an important date: May 26, 2024.
This is the deadline for transitioning to the Medical Device Regulation (MDR) 2017/745.

confinis strongly advises its clients to take the following steps:

Evaluate Your Portfolio: Assess which of your products are affected by the MDR transition and ensure access to the extended transition timelines granted by the EU Regulation 2023/607.

Ensure Compliance: Verify that your Quality Management System (QMS) is aligned with MDR requirements and initiate the certification process with a Notified Body, if necessary.

Certain conditions allow for an extended transition period, such as having lodged an application with a Notified Body by May 26th, 2024 and have a contract signed by September 26, 2024, and ensuring your devices continue to comply with previously applicable EU legislation without significant changes in design or intended purpose.

Stay Informed: Regulations and guidelines are subject to updates. Stay abreast of these changes to navigate the transition smoothly.

confinis is here to support you

Should you have questions or need further clarification, don’t hesitate to reach out. We are committed to facilitating a seamless transition for you.

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