Are you aware that new legislation on how medical devices are regulated comes in to play from 5th May 2020? If not, you can find out everything you need to know here in our handy guide…
What is it?
The change from the decade old Medical Device Directive (MDD) that provided guidance on how to regulate medical devices. Every member state could interpret the MDD in their own way. Now, MDD becomes MDR – a regulation, a law. Now all countries (competent authorities) will follow a harmonised set of rules.
When does this happen?
It started over seven years ago and was made into law May 2018. Now medical device manufacturers, Notified Bodies and Competent Authorities that watch over medical devices, and basically everyone else needs to fall in-line with the rules no later than 5th May 2020. Being non-compliant means the manufacturer will be required to withdraw their devices from any future sales as of May 2024. There is no impact on products already in the marketplace.
MDR and Brexit
The MDR will apply to all current EU Member States AND the UK will be included regardless of the final withdrawal agreement & potential implementation date
Additional and new rules for Notified Bodies
There used to be over 80 Notified Bodies in Europe, now there are less than 50 and this number is expected to keep shrinking. MDR set new rules for how to run a Notified Body (NB) including a rigorous audit process to secure MDR designation. Not all Notified Bodies will survive this new rigorous process, currently only Cardiac Science Corporation’s NB BSI has achieved MDR Designation for both of their offices (Netherlands and the UK).
Additional and new rules for Manufacturers, Distributors, and Suppliers
The MDR created more stringent rules and increased controls for manufacturers, distributors and suppliers. Controls that will need to be demonstrated when their Notified Body recertifies them to the MDR and during audits. It is expected that not all medical device manufacturers will be able to achieve this new higher bar of expected excellence and as a result will be required to withdraw the equipment / device from future sales once their existing CE Mark Certificate (EC Cert) has expired.
Cardiac Science is ready. We already use the 1st ever MDR certified Notified Body, BSI (The British Standards Institution). BSI is also prepared for Brexit by qualifying a site in the Netherlands as well. The Cardiac Science documentation has already been reviewed for increased expectations with the US FDA and is ready for the MDR in all respects. The process to transition from MDD to MDR has already begun at Cardiac Science and will be complete well before deadlines. Currently the BSI is THE ONLY MDR Designated Notified Body. Only about 7-10 more are expected to achieve MDR designation in 2019. This is going to have tragic capacity constraints for anyone NOT with BSI with the potential knock on effect of capacity constraints on the number of different AEDs available to end users.
Questions you may have...
As an AED customer, do I need to do anything?
There is nothing for you to do specifically, but we recommend that you ask any medical device manufacturers you are doing business with or considering using what their plan is to comply with the MDR. Don’t be afraid to ask for details.
How do I know if an AED is MDR compliant?
Ask the medical device manufacturer to provide evidence from their MDR Designated Notified Body that the device is MDR compliant.
What happens to equipment being sold with the CE mark from an NB that fails to exist because of the new regulations?
Equipment currently on the market (ie already been sold to customers) there will be no impact. However, no new equipment will be sold with the CE mark number of any NB that is not MDR designated after 2024.
What happens if I buy a device that is not MDR compliant after 2024?
Inform the Notified Body – their CE Mark number on the label is their identifier. Inform your country’s competent authority (regulator) as it is their job to enforce this regulation. If the device is not compliant with MDR then it is being illegally placed on the EU Market.
If you have any additional questions please contact us: EUMDR@cardiacscience.com