Our Blog
The new UK Medical Device Regulation is due soon: is your appointed UKRP ready?
The final UK Regulation text is scheduled to be published from Spring 2023, so manufacturers should be assessing their current provider to ensure they meet the compliance requirements to keep their devices in the UK market. UK MDR: new requirements for UKRPs and...
Medical Device Field Safety Corrective Actions
EU lay of the land Medical devices, like all products can potentially go wrong. Robust processes are usually in place at manufacturing organisations to help prevent safety problems, but even the best designed product can be found later to have unexpected design or...
Switzerland’s Parliament Moves to Accept FDA approved Medical Devices
On the 28 Nov 2022, Switzerland’s Parliament took a decision to instruct the Federal Council to incorporate the acceptance of medical devices approved by the United States (US) Food and Drug Administration (FDA) into national law. In recent months Switzerland...
How to advertise your medical devices in the UK and avoid enforcement.
The control of advertising medical devices in the UK is based on a system of self-regulation. This is supported by the statutory role of the UK Competent Authority, Medicines and Healthcare products Regulatory Authority (“MHRA”), acting on behalf of the...
IVDR Transition and Notified Bodies…… Early engagement is still critical!
If you are currently providing a UKRP service or if you are an Ex-UK Medical Device or IVD manufacturer who requires the services of a UKRP, you should consider the following information very carefully. This is the 2nd article in a 3 day, 3-part series which considers...
Have you appointed the right UKRP? Part 3
This is the 3rd article in a 3 day, 3-part series which considers some of the upcoming changes to the UK devices regulations and the implications on the UKRP legal service. 1. Agreements Response to Consultation, 12.2, The changes to the UK Regulations will require...
Have you appointed the right UKRP? Part 2
If you are currently providing a UKRP service or if you are an Ex-UK Medical Device or IVD manufacturer who requires the services of a UKRP, you should consider the following information very carefully. This is the 2nd article in a 3 day, 3-part series which considers...
Have you appointed the right UKRP? – Part 1
If you are currently providing a UKRP service or if you are an Ex-UK Medical Device or IVD manufacturer who requires the services of a UKRP, you should consider the following information very carefully. This is the 1st article in a 3-day, 3-part series which considers...
IVDR Transition and Significant Change…… What’s a Significant Change?
Regulation (EU) 2017/746, IVDR, is in place, and the market is in a 2nd phase of transition. But what should manufacturers know about this period of transition? And what are the new challenges that are introduced because of the conditions put in place? In this series...