Christmas is coming?
Laura Friedl-Hirst
Managing Director @ LFH Regulatory Limited | Regulatory Affairs I Quality Assurance I Clinical Affairs I UKCA & CE Marking I FDA I QMS I ISO 13485 I Global Registrations
Hi,
With #Christmas fast approaching, let’s take a look at what the final quarter of 2022 has brought to LFH Regulatory Limited ...?
Medica Trade Fair?
What did we learn??
We recently returned from the MEDICA - Leading International Trade Fair in Dusseldorf, Germany, so let's recap our time there. We had a blast meeting up with some very knowledgeable professionals within the healthcare industry, such as Globus and discussing the future of the medical device industry.? ?
We had lots of interesting conversations that highlighted certain areas of current concerns for current device companies:?
We will be working to spread knowledge in relation to #UKCA requirements and how to access the UK market once CE marking is no longer available. It was great to get so many new ideas and perspectives on how the medical device industry is changing.?
Christmas fun at LFH Regulatory?
The festive season has landed?
领英推荐
It's been a while since we've had an opportunity to get together as a team and have some fun, so we decided to go all out: we went to the Crystal Maze in Manchester, and it was...challenging.?
We had a blast—but the real highlight was seeing how much fun everyone had together. It was great to build up our teamwork, eat delicious food and celebrate with drinks.?
Whilst we’re talking Christmas, remember that our offices will be closed from Friday 23rd December, but we’re back open on Tuesday 3rd January 2023.?
New blog post alert!?
UK Responsible Person – what are the requirements?
In our recent article, we discuss how non-UK manufacturers should now appoint their own UK Responsible Person (UKRP) if placing medical device(s), including IVDs, custom-made devices and system or procedure packs on the UK market. ?
The #MHRA announced in October 2022 that there will be a 12-month extension to the implementation of the future UK Medical Device Regulations (July 2024), but there is still a requirement now to have a UKRP for selling devices on the UK market. ?
If you want to appoint your own UKRP, you will need a “letter of designation” that states the company name and address for both the non-UK manufacturer and the UKRP. ?
LFH Regulatory Limited has a registered UK office and can act as your UK Responsible Person. We can help ensure you meet all applicable requirements, so that you remain in compliance!