On 21 May 2024, the MHRA published a Statement of policy intent: international recognition of medical devices update. This exciting development means that MHRA will start accepting medical devices that already meet EU, USA, Australian, and Canadian regulations with conditions. CLIN-r+ explains the succession of events that has brought us to this point and what the future holds for manufacturers entering the UK market.
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 answers…
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 these answers and much more…
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 information should be included in statements regarding “Intended Purpose” or “Indications for Use”?
We explain the answers to these questions and lots more…
Intended Purpose, Intended Use and Indications for Use FAQ Read More »
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 MDR or IVDR?
We have the answers to these questions and more…
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 to these questions and more…
What is a Quality Management System (QMS)?
Why is it important?
How does it work?
We have the answers to the questions and more…
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 equivalence under the EU MDR?
We answers your questions and more…
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…
Recent changes to ISO 10993-1 have changed the landscape of medical device biological safety testing. The toxicity test box ticking from the biocompatibility test matrix is no longer used. Materials analysis, chemical risk analysis, analytical chemistry, and toxicological risk analysis have all been introduced. Clin-r+ explains what you need to know.
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