Some of the hot topics
The In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published and comes into force in May 2022. From this moment all IVDs must comply with the new IVDR. At the moment around 20% of IVDs require notified body intervention prior to be being placed on the market, under the new regulation this will increase to around 85%. The new regulation has many more requirements than the current directive and whilst most are not going to prove ‘difficult ‘ to implement, there is much to do in the time left available. The aim of this event is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance to navigating the additions and expectations of the law.
Get to know the Trainer
My name is Richard Tully, currently the Director at Compliant Medical Devices Ltd.
We are a medical device consultancy company who specialise in the European and Saudi
Regulations. I started my professional life as an electrical engineer and had a lot of fun working
off-shore and in dozens of different factories as part of a specialist electrical company. I went
back to school at Brunel University to play with much lower voltages and completed my Masters in
silicon design. I remained in engineering and expanded into mechanical, pneumatic and software
design.
In 2005 I joined a small company designing anaesthetic equipment targeted at developing
countries. These products are now sold in over 40 countries worldwide.
I joined a Notied Body as a Technical Expert in 2011 and spent more than six years auditing and
teaching all over the world.
In 2017 I moved into consultancy where I enjoy doing much the same, supporting manufacturers
as well as Notied Bodies and a Competent Authority.
Feel free to suggest the topics that you would like to learn about at
our Blockchain for Pharmaceuticals In-house Training.
Request an Offer
Who should attend?
• IVD Regulatory Affairs managers
• IVD Quality Managers
• IVD Quality Engineers
• Manufacturers of IVDs for the EU
• Designers of IVDs for the EU
• Anyone tasked with IVDR implementation
