The UKCA marking

If you are still not sure of what you need to do after your #CE expires in GB, watch the video and ask yourself the following questions: 1. Do I need to apply new standards under #UKCA marking? 2. Is there anything I need to add or adjust to my TF? 3. Do I need to retest via an Approved Body? 4. How and when do I need to register my device with the #MHRA? 5. Do I need a #UKRP? 6. Do I need an importer? 7. Is there anything I need to adjust on my #ISO13485 QMS such as #PMS, #PMCF, reporting, adverse incidents, etc? 8. Will other CE Directives such as #RoHS apply in GB? 9. What will happen to my #UDI-DI? Do I need it? ? Clarity from design to market™️ MedicalRegs ? ?We offer results-oriented consulting services powered by professionals with medical device R&D, product certification agency, and regulatory agency experience.