Updated MHRA Guidance on Clinical Trials

The MHRA updated their guidance regarding notification of clinical investigations for medical devices on 1st October 2019. The updated guidance ...

And BSI makes 7

We now have seven Notified Bodies designated under Regulation (EU) 2017/745 on medical devices, the newest of which is BSI Netherlands,  ...

And then there were 4

So now we have 4 Notified Bodies designated under EU MDR. Unfortunately, one of these, BSI Assurance, is located in ...

Notified Bodies dropping like flies

One of the biggest challenges facing Notified Bodies at the moment is their re-designation under MDR. For some, this challenge ...

Do you need a UK Representative?

Brexit day is almost upon us and whilst the final outcome is still unknown, one thing is (almost) certain, the ...

Are you ready for Brexit??

We are delighted to announce the formation of Annette Callaghan (Ireland) Limited, a legal entity based in Cork which is ...