Article 59 (EU MDR) and CE Marking FAQ
What is Article 59?
What’s its purpose?
When is it appropriate to use it?
We answer these questions and more…
EU MDR
Medical Device Non Conformances
Non-conformances (NCs) and non-conformance reports (NCRs) are important for medical device manufacturers to understand and manage correctly. CLIN-r+ highlights the key information that manufacturers need to know.
EU MDR Article 59 and CE Marking for Medical Devices
Article 59 sets out how authorisation of CE Marking requirements derogation for medical devices (not IVDs) can be done. Clin-r+ provides guidance on Article 59 and CE mark derogation.
EU MDR Article 59 and CE Marking for Medical Devices Read More »
Common Standards
ISO standards help medical device manufacturers and the medical industry comply with the evolving ‘State of the Art’, international best practices, streamline processes, and improve patient safety and satisfaction. These standards improve risk management and help businesses fulfil legal and industry standards. There are numerous ISO standards in place, and Clin-r+ has constructed this paper to give you an overview of the most common standards for the MedTech industry.
Orphan Medical Devices
The EU MDR’s regulations on clinical data ensures that the medical device being used on the general public for their treatment or diagnosis is safe. However, there is a category of devices, known as ‘orphan medical devices’, that may suffer if special consideration isn’t provided to it. CLIN-r+ looks at what they are and what this means.
Gap Assessment
An MDR gap assessment is the process of looking at a medical device’s technical file in a systematic way to determine if it meets all of the relevant MDR requirements. It is the first and most important step in understanding what needs to be done for a device to become MDR compliant. CLIN-r+ shows how a gap assessment can quickly identify important information.
EU MDR Requirements for Implant Cards
EU MDR requires manufacturers to provide “implant cards” for patients with implanted medical devices. The intention is to make crucial information about implants easily accessible to patients. CLIN-r+ explains what manufacturers are responsible for.
Technical Documentation FAQ
Are there any guidelines for the structure of the Technical Documentation?
What should be in each section? What do Notified Bodies expect to see?
We have all the answers…
EU MDR Readiness Checklist
Clin-r+ Ltd can assist medical device manufacturers with gap assessments and the transition to MDR. An EU MDR Readiness checklist can assist in efficient planning. It should be a practical tool that ensures you are compliant with the regulations.
Claiming Equivalence under EU MDR
Manufacturers can circumvent the time and expense of conducting clinical studies to satisfy the safety and performance requirements as outlined in the clinical evaluation by claiming equivalence with another device to get CE certification under the MDR.
