Medical Device News: UKCA & much more
Monir El Azzouzi
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
Agenda
Podcast release
Since Brexit happened, there are multiple waves of changes in the UK. First the UK Responsible Person (which is a hybrid of the EU AR and the EU Importer), then the UKCA requirements, then the new legislation consultation (which will largely harmonize UK law with the MDR and IVDR), and now the extension of the unilateral recognition of CE Marks to allow manufacturers more time to obtain UKCA marks.??
But what does all this mean for medical device manufacturers that are already selling in the UK or that plan to sell to the UK? We will review that with Alex Denoon, partner at Bristows.?
Don’t forget to check the links below for more details.?
Who is Alex Denoon??
Alex advises about Life Sciences regulatory issues all day every day and has been doing so for 30 years.?
He enjoys working with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals, medical devices and IVDs.?Alex has been involved in the development of a number of regulatory frameworks and guidelines. Legal 500 describes Alex as “a straight-talking, commercially astute technology specialist who is always willing to take a view” and who delivers “out-of-the-box solutions”.?
How to create your Technical Documentation for EU MDR?
You need to understand that the Technical Documentation for EU MDR and even for a 510k, is usually happening at the end of your project. You should imagine that the Technical Documentation is like a puzzle that is finished. We see the full picture. But before assembling the puzzle, you will need to identify all the pieces of the puzzle. The Clinical Evaluation, the Design file, the Labels, IFU, testing reports... So without these pieces of the puzzle, you cannot create the technical file.
As soon as you understand that then you understand that this may need a lot of time for you to create all the documentation needed for it.
Below is a link to a blog post I have made on the creation of Technical Documentation.
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At Easy Medical Device we have helped a lot of different companies to create and submit a Technical Documentation and you should understand that this is never going through the first time. We always get an answer from the Notified Body with questions. Sometimes, we know there is a weak point and try to provide some arguments but this may not be accepted. The important information is that you have 3 rounds of questions only so the Notified Body is then restarting the process from zero.
Let us know if you have some questions
What is an Authorized Representative?
This is an entity that is located in a region where you want to sell your products. In Europe for example, you need to appoint an EU Authorized Representative if you are not located in Europe. Same for UK or Switzerland.
Their role is mainly to be the joint between the manufacturer and the health authority. If anything wrong is happening in the market, the EU Authorized Representative should communicate the information to the Health Authority or help the Health Authority understand the situation. The Authorized Representative is liable to anything happening to the products on the market so this is also a role which is sharing some responsibility with the manufacturer.
Here is an article explaining more about the EU Authorized Representative.
Easy Medical Device is also acting as Authorized Representative so don't hesitate to contact us.
Easy Medical Device support
At Easy Medical Device, we are committed to supporting you achieve your compliance with the legislation. For that, we are offering consulting, training, authorized representative, and importer services.
In partnership with Scube Technologies, we are also offering an eQMS called SmartEye. Check it at https://smart-eye.io
So if you need any support to:
Contact us: easymedicaldevice.com