Book my call

Technical Documentation

UKCA - MHRA update: International Regulation Framework

UKCA MHRA International Regulation Framework

Regulatory Strategy /

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.

UKCA MHRA International Regulation Framework Read More »

Intended Purpose, Intended Use and Indications for Use FAQ

FAQS /

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 »