Changing your MDD certified medical device? What next?
Got a change to make to your MDD certified medical device? What next?
For many manufacturers of medical devices, change is often the only constant. Sometimes this change comes from a desire for product enhancement, providing new features to improve patient outcomes or the user experience. At other times a manufacturer may be obliged to make a change due to component obsolescence or customer complaints.
Until May 2024, many medical device manufacturers will be continuing to place their current devices on the market under a valid CE Certificate issued under the Medical Devices Directive (93/42/EEC, “EU MDD”).
The Medical Devices Regulation (EU) 2017/745, “EU MDR” places new obligations on EU MDD devices in Article 120(3) for assessment of product changes – “there are no significant changes in the design and intended purpose”. If significant changes to the design and intended purpose are implemented, the product can no longer be certified under the EU MDD, and must transition to the more rigorous EU MDR certification.
So, what do you do if you need, or want, to change your product?
Firstly, you need to ensure that assessment of significant change under the EU MDR is incorporated into your change control process. Make sure that you are following the guidance from the Medical Devices Coordination Group, on significant changes regarding the transitional provision under Article 120 of the EU MDR – MDCG 2020-3
If you follow the guidance and identify that the change is not considered significant, you can implement the change. But you still need to document your rationale, as this will be considered by your Notified Body, as part of their surveillance processes for your EU MDD CE Certificate.
Please note that even if the change is not considered significant under MDCG 2020-3, it may still need to be reported to your Notified Body, particularly for devices subject to design examination or type examination under the EU MDD. So, you should also assess the change under EU MDD requirements.
And if the change is significant under the EU MDR?
If your change qualifies as significant, consider the following questions:
- Can you limit the scope of the change? If so, does that alter whether the change is significant under the EU MDR?
- Can you limit the geographic availability of your product? You may not be able to make the changed device available in the EU or other territories, which leverage the CE mark. However, you might be able to seek marketing clearance in other jurisdictions, depending on the requirements for change notification in those territories. In the meantime, can you keep stock of your unchanged current CE-marked device? Do bear in mind that you will need to have processes in place to segregate your CE-marked and non-CE-marked stock.
- Can you transition the product to the EU MDR? This is of course dependent on your Notified Body’s capacity to review your Technical Files and audit your organisation, which could cause delay, but it’s an option that you may still wish to discuss with them.
Any time you are considering a change to your device, IMed can help you determine whether it would be classed as significant or not – and even if it is, we can work with you to find a solution, which keeps your product on the market. If you need any help with product changes, just get in touch with us on 01295 724286 or drop us an email at firstname.lastname@example.org, and we will be sure to help you.
IMed QA/RA Consultant