December 18, 2023
Step-by-step guide on how to register medical devices & IVDs with the UK MHRA. Includes necessary links and screen-shots to walk you through the process.
November 20, 2023
Find out the importer’s requirements under the MDR/IVDR. Plus, what are the manufacturer’s obligations to/from the importer and how are direct sales handled?
October 24, 2023
Overview of Shelf Life, Expiration Dates, Device Lifetime/Useful Life and Service Life for medical devices and IVDs in Europe.
June 9, 2023
Page Last Updated: 20 December 2023 Definitions: Systems, Procedure Packs, Kits Systems and Procedure Packs MDR, Article 2(10): “‘procedure pack’ means a combination of products packaged […]
June 2, 2023
Clinical Evaluation Plans are a critical part of medical device clinical evaluation under the MDR. Find out how to get it right.
April 28, 2023
Find out how to register in the UK MHRA's new MORE vigilance platform. The page includes the steps, templates, e-mail addresses and deadlines to comply.
April 18, 2023
Comprehensive guide to EU MDR transition period extension per Regulation 2023/607. Included: timeline of key dates, FAQs, & Before vs After table of the changes.
February 20, 2023
Most will make use of the UKCA delay & CE Marking transition period. However, there is an advantage to UKCA Marking for some low-risk devices. Find out why.
February 8, 2023
Find out the steps and timing to transfer your Swiss Authorized Representative (CH-REP) for medical devices and IVDs.