MedTech’s most Frequently Asked Questions
Struggling with the EU Medical Device Regulation (MDR) or IVDR? Say goodbye to frustration with our frequently asked questions (FAQ)!
Welcome to your ultimate FAQ destination. Our experts have compiled the most common questions (frustrations) manufacturers face, providing clear answers. No more searching through countless documents or forums. Find concise and accurate information here, saving you time and reducing frustration. From regulatory requirements to compliance strategies, we cover it all. Empower yourself with knowledge and resources to navigate EU MDR successfully. Contact CLIN-r+ to unlock smoother regulatory compliance today!
510k vs MDR FAQ
What is the difference between FDA and EU MDR regulations for medical device approvals? How do they differ? What are the requirements? We answer these questions and more...
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...
Biocompatibility FAQ
What is biocompatibility for a medical device? Why is it needed? What does it do? We have all the answers and more...
Claiming Equivalence FAQ
What is the difference between claiming equivalence under EU MDR compared to MDD? What are the key requirements for demonstrating equivalence? What can improve the process of demonstrating ...
Clinical Development FAQ
What is a Clinical Development Plan (CDP) under the EU MDR? Why is it important? How does it differ? We answer these questions and more...
Clinical Evaluation Assessment Report FAQ
What is a Clinical Evaluation Assessment Report (CEAR)? What is its purpose? Why do medical devices need one? Read on to learn more...
Clinical Evaluation FAQ
What is Clinical Evaluation? What guidance is there? What documents do you need? We have the answers...
Clinical Investigation FAQ
What are clinical investigations according to the EU MDR? Why is clinical data required? What types of clinical investigation can be conducted? We have all the answers and ...
Common Standards FAQ
Why are ISO standards important for manufacturers? What are Harmonised Standards? How do you determine which are applicable? We have all the answers and more…
Conformity Assessment Procedures under MDR FAQ
What is the process for demonstrating conformity of devices? How does this differ depending on device class? We have the answers and more...
Consultancies vs Agencies for Clinical Regulatory Affairs FAQ
What is the difference between consultancies and agencies for Clinical Regulatory Affairs? Should you work with an external agency or a consultancy? We explain all…
Economic Operators FAQ
What does "Economic Operator" mean? Who does it apply to? What are their responsibilities? We answer these questions and more…
EU MDR Readiness FAQ
What steps should be taken to prepare for compliance with EU MDR How do you formulate a project plan? How do you review Technical Documentation structure for EU ...
EUDAMED FAQ
What is EUDAMED? What's its purpose? What information does it store and how? Read on to learn more...
Gap Assessment FAQ
What is a Gap Assessment? How can it help? What does it involve? Read on to learn more…
Implant Cards FAQ
What is the purpose of an implant card? When are they applicable? What are the guidelines? We have all the answers and more...
Instructions For Use and Labelling FAQ
What is the purpose of Instructions for Use (IFU)? What does it need to include? How do you create MDR compliant labels? We have all the answers…
Intended Purpose, Intended Use and Indications for Use FAQ
Why is the "Intended Purpose" important for medical devices under EU MDR? What are the key differences between "Intended Use" and "Indications for Use" for medical devices? What ...
MDD vs MDR FAQ
What is the difference between the Medical Device Directive (MDD) and the Medical Device Regulation (MDR)? What are the main changes? When do you need to be compliant ...
Medical Device Design FAQ
What are the EU MDR requirements for device design? How does it affect your QMS? What changes are needed? Read on to learn more…
Non Conformances FAQ
What is a Non Conformance? What is CAPA? How should non-conformity procedures and processes be set up? We have all the answers and more…
Nonconformities for MDR submissions FAQ
What are common nonconformities identified under the EU MDR? What does a Notified Body want from your Technical Documentation? What can mitigate risks and ensure compliance? We have ...
Orphan Medical Devices FAQ
What are Orphan Medical Devices? How are they regulated? How does EU MDR impact orphan medical devices? We explain all…
Performance Evaluation for IVDR FAQ
What documents and resources are needed for performance evaluation requirements under IVDR? What is involved in the performance evaluation process for IVDs under the IVDR? We have the ...
Periodic Safety Update Report FAQ
What is a Periodic Safety Update Report (PSUR)? Which devices require one? What are the requirements? We have the answers and more...
Person Responsible for Regulatory Compliance FAQ
What is a Person Responsible for Regulatory Compliance (PRRC)? Who needs one? Who can be one? What do they do? We answer these questions and more…
Post CE mark FAQ
What do you need to do after obtaining a CE mark? What is involved in updating Technical Documentation post-CE mark? We answer these questions and more…
Post Market Clinical Follow up FAQ
What is Post Market Clinical Follow-up (PMCF)? What is the point? What do you need to be compliant? Read on to learn more…
Post Market Surveillance FAQ
What is Post Market Surveillance (PMS)? What's it used for? Why do you need it? We have all the answers and more…
Quality Management System (QMS) FAQ
What is a Quality Management System (QMS)? Why is it important? How does it work? We have the answers to the questions and more…
Risk Management FAQ
Why do manufacturers need Risk Management? How is it defined for medical devices? What ISO is applicable? We have all the answers…
State Of The Art FAQ
What does "state of the art" mean in the context of medical devices? Why is it important? What do you need to do? We answer these questions and ...
Summary of Safety and Clinical Performance FAQ
What is the Summary of Safety and Clinical Performance (SSCP)? Does it apply to your device? Where can you find guidance? Read on to learn more…
Sustainability FAQ
Why is sustainability important in medical device development and manufacturing? What impact does it have? What is important to consider? Read for the answers…
Systematic Literature Review (SLR) FAQ
Why do you need a systematic literature review? What steps are involved? What are some key reasons for non-conformances in literature reviews during audits? We have the answers ...
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 ...
