And so this has happened - The new European Medical Devices Regulation (MDR) has been finalised and published in the Official Journal of the European Union, as Regulation 2017/745. The Regulations has come into force on 25th May 2017, marking the start of the transition period for companies selling medical devices into Europe.
Now that you have medical devices already selling in Europe or are planning to get into the European market, how is this change going to impact your business?
Out of an entire list of implementations in the EU MDR, we have handpicked SIX of them that are likely to affect most of you. Here they are:
#1: More products get classed as ‘Medical Devices’
With the creation of new classification rules, such as the one for software, many companies will be impacted.
‘A software that drives a device or influences the use of a device’ is now classified as a medical device. With a recent trend in more digital health products and technologies, it is now more important to verify if your software platforms get classified and controlled as a medical device.
#2: More stringent evaluation for some classes of medical devices
If you are in the business of any high risk implants or medical devices that are administering and/or removing medication from the patients, you would now need to submit your clinical evaluation report for an assessment by a group of external experts, before the auditors can certify your devices. This was not required previously.
#3: Increased commitment to demonstrate safety and performance of medical devices
Companies have to continuously show that their devices are safe for use and can perform as required. This includes documents such as post-market surveillance plan/report, post-market clinical follow-up reports, periodic safety update reports, and summary of safety and clinical performance. More resources have to be allocated so that all these activities can be diligently carried out!
#4: Increased auditing and inspection requirements
The Notified Bodies are told to perform unannounced inspections on the Product Owners. As for their suppliers or subcontractors, an unannounced audit will be performed at least once every 5 years.
#5: More clinical data required
The clinical evaluation requirements have been given great emphasis. A set of new and stringent criteria are introduced, and this means that more clinical data must be collected, especially for the higher risk devices.
#6: The rise of the EUDAMED database
A lot more activities have to be transacted through the EUDAMED database now. For example, the reporting of incidents, injuries or death related with the use of the medical devices must now be reported via the EUDAMED database. Another implementation will be the introduction of a unique identifier (UDI) for all medical devices. The registration process is now done via the EUDAMED database.
This common EUDAMED database ensures that any such information can be easily shared and retrieved within all the European member states.
The Solution to your Uncertainty
As mentioned, these SIX implementation are not the entire list of what the EU MDR has spelt out. To find out in full details on what are the DOs and DON’Ts with regards to this new regulation, we would like to invite you to attend our upcoming workshop next month.
We cannot emphasis more on how crucial it is to completely understand the importance of this implementation and how it can impact the commercialisation of your product.
To find out more about the workshop, click here and don’t forget to grab your early-bird discounted tickets before it runs out.
Next week, we will also be providing you with more details on the EU in-vitro Diagnostic Regulation (IVDR)! Stay tuned to our blog site or subscribe to us to not miss out on any actions!