Knowledge Center
EU Guide: Risk Management Concepts and Terminology & MDR/IVDR Application of ISO 14971
Find here an overview of risk management concepts and terminology under ISO 14971 and the MDR/IVDR. Plus, examples of how ...
EU Guide: Medical Device Accessories under the MDR/IVDR
Find out exactly what an accessory is compared to a medical device, examples, how accessories are classified, and overall CE ...
Clinical Evaluation Reports: General Structure and What to Include
Clinical evaluations are mandatory for all medical devices marketed in the EU. Find out the specific requirements under the MDR, ...
UK MHRA Medical Device & IVD Registration: Step-by-Step Guide
Step-by-step guide on how to register medical devices & IVDs with the UK MHRA. Includes necessary links and screen-shots to ...
EU Guide: Importer Requirements under the MDR/IVDR
Find out the importer’s requirements under the MDR/IVDR. Plus, what are the manufacturer’s obligations to/from the importer and how are ...
EU Guide: Shelf Life, Expiration Date, Expected Lifetime/Useful Life, Service Life, Life Cycle
Overview of Shelf Life, Expiration Dates, Device Lifetime/Useful Life and Service Life for medical devices and IVDs in Europe.
EU, Swiss, UK Guide: Systems/Procedure Packs and Kits
Page Last Updated: 9 August 2024 Definitions: Systems, Procedure Packs, Kits Systems and Procedure Packs MDR, Article 2(10): “‘procedure ...
Clinical Evaluation Plans: How to get it right
Clinical Evaluation Plans are a critical part of medical device clinical evaluation under the MDR. Find out how to get ...
UK MHRA: MORE Vigilance Platform, New Account Creation Guide
Find out how to register in the UK MHRA's new MORE vigilance platform. The page includes the steps, templates, e-mail ...
MDR Transition Extension Guide
Comprehensive guide to EU MDR transition period extension per Regulation 2023/607. Included: timeline of key dates, FAQs, & Before vs ...
Is There Any Advantage to UKCA Marking Early?
Most will make use of the UKCA delay & CE Marking transition period. However, there is an advantage to UKCA ...
Transfer your Swiss Authorized Representative (CH-REP): Steps and Timing
Find out the steps and timing to transfer your Swiss Authorized Representative (CH-REP) for medical devices and IVDs.
List of EU MDR/IVDR Harmonized Standards & Common Specifications
Full list of European MDR/IVDR Harmonised Standards & Common Specifications for medical devices & IVDs. How to find standards, and ...
EU MDR/IVDR Guide: Market Surveillance & Post-market Surveillance
Learn the difference between market surveillance & post-market surveillance. Plus how PMS Plans, Reports, PMCF/PMPF, Trend Reporting & Vigilance all ...
UKCA Marking: Fact Sheet for Medical Devices & IVDs
Read our Fact Sheet to find out: UKCA Marking deadlines; UKCA versus CE Marking technical file and labeling differences; where ...
Declaration of Conformity Requirements: EU, the UK and Switzerland
Find out how to create medical device Declarations of Conformity for Europe, the UK and Switzerland. Plus, Procedure Packs and ...
Transfer your EU Authorized Representative (EC Rep): Steps and Timing
Find out the steps and timing to transfer your EU Authorized Representative for medical devices and IVDs. Includes the process ...
EUDAMED Actor Registration FAQs
Find out the difference between an Economic Operator and Actor, who must register as a EUDAMED Actor and why you ...
Northern Ireland Medical Device Requirements
Northern Ireland has one foot in the UK door and one foot in the EU door. Find out what is ...
Labeling Requirements for the EU, UK and Switzerland In-Country Representative
Manufacturers selling in the EU, UK and Switzerland need to consider the different labeling requirements for listing their in-country representatives ...
Transfer your UK Responsible Person (UKRP): Steps and Timing
Is it possible to transfer your UKRP? Can I appoint more than one UKRP? Is a Transfer Agreement needed between ...
How to Find GMDN Codes for Free
Need a GMDN code? Find here the three best ways to find GMDN codes for free. Plus, how to confirm ...
Overview: Swiss Single Registration Number (CHRN) Requirements
Below is an overview of the Swiss Single Registration Number and how it applies to you. What is a Swiss ...
EU Guide: Legacy Device Transition Period Deadlines, Conditions, and more
In short, legacy devices are: MDD 93/42/EEC Class I self-certified devices, which have been up-classed under the MDR and therefore ...
EU Guide: Basic UDI-DI Requirements under the MDR/IVDR
While Basic UDI-DI was created to help streamline device identification, it continues to be a confusing concept to many.
Certificates of Free Sales for Medical Devices: Europe, UK and Switzerland
Do you need a European Free Sale Certificate for export, but not sure how to get one? Find out here ...
EU Guide: How to register medical devices & IVDs in EUDAMED
EUDAMED Module: UDI / Device Registration Once your Single Registration Number has been issued, you are ready to move foward ...
EU Guide: How to register your company in the EUDAMED “Actor” Module
EUDAMED Module: Actor Registration Company registrations are submitted in the EUDAMED Actor Registration Module. What is an Actor? Per the ...
EUDAMED Overview: EU Medical Device Database
EUDAMED is the European Database on Medical Devices. It is similar to other public government databases, such as the US ...
GMDN, EMDN & CND: Overview of differences, how to find codes, and where each is required
When do you need a GMDN versus EMDN versus CND? Are they linked? Where and how do you find the ...