Due to the introduction of MDR regulation, all companies that produce medical products certified with a CE mark according to the MDD directive have to undergo the MDD to MDR transition process to continue to sell their products on the EU market.
This article discusses the step-by-step process for a smooth MDD to MDR transition that will help avoid possible hiccups and save time and money.
Until you complete the transition, secure the continuous sale of your product
To secure your sales continuity, you mustn’t lose your certification before the transition period deadline, which is May 2024. To avoid that, you should:
Be mindful of any changes to your devices
The CE certificate is valid as long as you don’t make any significant changes to the product. Any modification to be implemented must be carefully assessed in terms of posing a new risk. Also, it must be checked if the intended use of a medical product remains unaffected. If the implemented change impacted either the risk level or the intended use, then it might result in losing the certification. If that happens, the recertification process would follow the MDR requirements.
Apply to the changed Post Market Surveillance (PMS) requirements
Due to the fact that the MDR already came into force, you need to follow the changed PMS requirements, even though your certification is compliant with the MDD.
Monitor new guidelines and adapt
The MDR regulation turned out to be imprecise in many aspects. Various companies interpret the regulations differently. To alleviate any doubts and clarify the requirements, the Medical Device Coordination Group (MDCG) of experts have published guidance on a range of topics, which are available on their website.
Prepare an action plan to ensure a smooth transition
As soon as you have those three areas under control and your sales continuity is secured, you can move forward to the next step, which is the MDD to MDR transition plan preparation.
What is the MDD to MDR transition process?
We’ve prepared a step-by-step MDD to MDR transition checklist that you can follow. The steps don’t have to be followed in this exact order – depending on your business case, the sequence may be slightly different.
Step #1 Verify your product’s classification
Firstly, you must determine whether your product qualifies as a medical product. MDR’s definition of a medical product is broader than MDD’s. For instance, software was not considered a medical device before.
The MDR introduced new, more rigid rules that especially impact the manufacturers of invasive devices intended for implantation, surgeries and other devices described as active, including the software used with such devices. The most serious change affected medical devices that belonged to class 1 under the MDD. Now they are at least in class IIa (there are very few exceptions when the devices remained in class I). The higher the risk class, the more strict the requirements are. You should verify if your product’s risk class has changed before you move to the next step.
Step #2 Update the documentation and labelling
Once you’ve verified your product’s risk class under the MDR, you should review and update the labelling accordingly. The MDR requires to add an MD symbol in a square frame. What is more, you should also update your bar code according to the requirements related to the UDI (see step #3 for more information about it).
It’s worth mentioning that the importers of medical devices (companies outside of the EU) must also include on the labelling the contact information and identification of their authorised representative in the EU.
Step #3 Make sure your product meets the UDI requirements
Your product should be assigned the three UDI numbers:
- Basic UDI-DI – used in EUDAMED and the Declaration of Conformity and as a reference in documentation to describe the category of products.
- UDI-DI and UDI-PI – used to tell apart various model variants or software versions, indicate product series, the production date, etc. Both UDI-DI and UDI-PI are included in the product’s bar code.
Your company should plan out the strategy of how the UDI numbers will be assigned, how your products will be grouped, etc. All this information has to be documented. In the future, when EUDAMED is operational, all the UDI numbers will have to be uploaded to the database.
The UDI numbers are important because they are used to trace the product in case of an adverse event, for reporting purposes or when the product has to be withdrawn from the market.
Step #4 Choose a Notified Body
Only the manufacturers of class I medical products (non-sterile, non-surgical and without a measuring function) do not require a Notified Body audit. The manufacturers of medical products belonging to class IIa, IIb, III and some of class I (sterile, with a measuring function or surgical) must choose their Notified Body as soon as possible because the waiting time is quite long. However, keep in mind that when selecting a Notified Body, you should already know the Intended use and the class of your product, etc.
Step #5 Ensure you’re meeting all the obligations of a manufacturer
You can realise this step of the checklist at any stage of your MDD to MDR transition process, however, the sooner you begin, the better, as you’ll have more time to establish and adjust the procedures.
The obligations that you should meet as a manufacturer of a medical device, provided you already have the PMS in place, include among others:
- Assign the PRRC – Person Responsible for Regulatory Compliance.
- Register your company in the EUDAMED database.
For the importers, a crucial requirement is to assign an authorised representative. Be mindful that after Brexit, companies from the UK are also considered importers. Switzerland is regarded a third party too.
Step #6 Get audited and certified
The Notified Body usually conducts the audit and certification process. MDD to MDR transition is de facto treated like the market entry, even though the product might have already been for sale for years.
There are two audits that you have to go through. The first one will check your company’s readiness for certification. The second one is the actual MDR compliance audit. Once your company passes the audit, you can sign the Declaration of Conformity. The Declaration of Conformity states that the requirements specified in the MDR regulation have been fulfilled in relation to your device. The date of signing the Declaration is the same as the date of introducing the product to the market under the new regulation.
Step #7 Continuous compliance
Maintaining continuous compliance with the regulation and sticking to the established procedures and reporting requirements at all times is very important.
What is the timeline for MDD to MDR transition?
The current CE certificates are valid until May 2024. Past this date, all medical devices need to be certified as per the new MDR regulation.
Do you need help with the MDD to MDR transition?
Our consultants have extensive experience in the medical device industry and MDR regulation.
We operate in two stages, always in close cooperation with the client. In the first stage, we check to what extent your product meets the regulatory requirements. In the second stage, together, we discuss how we can address these issues. We also suggest good practices and solutions to help you secure compliance with the new regulation.
See our offer and book a no-obligation meeting with one of our experts.
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