Resources
Guide: Systems/Procedure Packs and Kits
Definitions: Systems, Procedure Packs, Kits Sytems and Procedure Packs MDR, Article 2(10): “‘procedure pack’ means a combination of products packaged ...
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 ...
Steps and timing to transfer your Swiss Authorized Representative (CH-REP)
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
Click here to access a list of the European MDR/IVDR Harmonised Standards & Common Specifications. Casus has centralized these into ...
MDR/IVDR 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 ...
Steps and timing to transfer your EU Authorized Representative (EC Rep)
Find out the steps and timing to transfer your EU Authorized Representative for medical devices and IVDs. Includes the process ...
‘Placing on the Market’: Definition and Cutoff Dates for EU, UK & Switzerland
Why does 'placing on the market' matter? EU definition of 'placing on the market' UK definition of 'placing on the ...
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 ...
Steps and timing to transfer your UK Responsible Person
Is it possible to transfer your UKRP? Can I appoint more than one UKRP? Is a Transfer Agreement needed between ...
What Happened to the European Single Market?
What happened to the European Single Market? The United Kingdom left the European Union and is now a Third Country. ...
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 ...
What is a CHRN (Swiss Single Registration Number)?
Below is an overview of the Swiss Single Registration Number and how it applies to you. What is a Swiss ...
Switzerland Steps to Market
Click here to see an overview of the steps to register and sell your medical devices and IVDs in Switzerland.
EU Steps to Market
Click here to see an overview of the steps to sell your medical devices and IVDs in the EU.
What are Legacy Devices?
In short, legacy devices are: MDD 93/42/EEC Class I self-certified devices, which have been up-classed under the MDR and therefore ...
UK Steps to Market
Click here to see an overview of the steps to sell your medical devices and IVDs in the United Kingdom.
Basic UDI-DI
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
Do you need a European Free Sale Certificate for export, but not sure how to get one? Find out here ...
Registering Devices in EUDAMED
EUDAMED Module: UDI / Device Registration Once your Single Registration Number has been issued, you are ready to move foward ...
Actors, Economic Operators: How do you register your company in EUDAMED?
EUDAMED Module: Actor Registration Company registrations are submitted in the EUDAMED Actor Registration Module. What is an Actor? Per the ...
EUDAMED Basics
EUDAMED is the European Database on Medical Devices. It is similar to other public government databases, such as the US ...
GMDN, EMDN and CND: What is the difference?
What's New in Nomenclature? Regulatory agencies around the world have long struggled with how to more easily identify groups of ...
What is a EUDAMED SRN (Single Registration Number)?
A Single Registration Number (SRN) is a unique number assigned to your organization by a European Competent Authority. SRNs are ...
