In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings
CE marking indicates compliance with an EU directive so that you can market your products in the EU.
It’s that simple.
CE marking is a voluntary conformity assessment procedure, but it is a requirement if you plan to market your product on the European market.
The letters “CE” stands for Conformité Européenne (French), which means “European conformity.” The CE marking indicates that a product meets all relevant European health, safety, and environmental requirements and is legal to sell across Europe.
As far as medical devices are concerned, they need to be certified via several processes, including notified bodies, before they can be sold in the European market.
How CE markings work
CE marking is visible, with relevant product safety Directives. It shows that the manufacturer has assessed the product and placed it on the market with the required safety features and in line with European legislation. In other words, the CE marking on products sold in the European Union (EU) indicates that the medical device manufacturer has declared that the product meets all applicable EU health, safety, and environmental protection legislation.
Notice that having the CE marking does not ensure the quality of the product. It merely shows that the company claims they have all the required documents. At least, that’s how it was up until a few months ago.
CE marking under IVDR requirements
Before the IVDR requirements were enforced, in vitro diagnostic devices did not require conformity assessments. Previously, under the IVDD, most companies decided to self-declare their conformity to European standards, which involves checking that their products comply with applicable requirements.
However, CE markings for most of these devices will now be given after a quality check by the notified bodies. The classification of IVD devices enforced by the IVDR also means the scope of the IVDR requirements is also more encompassing than the IVDD.
According to many specialists, before IVDR, around 85% of devices sold were CE marked without any form of clinical evaluation. Now the percentage has turned about 90% of the devices must be certified after notified body intervention.
Are classified as Class A no longer need to undergo Notified Body assessment.
The classification rules are based on the principle of risk management, which means that the risk associated with an IVD can be identified by its function and/or intended use. The revision will ensure that only those devices posing a high level of risk are subject to regulatory control by Notified Bodies (NBs).
Roadblocks in getting CE marked
The number of notified body available for IVDR approval are scarce, so there is a rush in manufacturers to book their slots. Not to mention the application date for IVDR has already passed. So, the countdown to getting complete certification is on.
The preparations needed to get IVDR CE certifications are extensive, to say the least. Each device may take any time from 5 to 12 months to get fully certified, and most manufacturers cannot hold off production for that long.
The added workload is also a bit high for many companies. SMEs especially are struggling under the added steps. The wait is even higher for the entrepreneurs that had started their journey with innovative, high-risk class D devices. Class D devices will now need to undergo an expert panel review and be clinically tested in certain pre-chosen labs before getting certified.
The EU is not blind to these plights.
One of the reasons there has been such a long transition period before the new regulations go into effect was that many manufacturers needed time to prepare and submit their applications to Notified Bodies prior to the cut-off date. There are also initiatives from the EU to make the transition go as smoothly as possible.
A few key points
Although the deadline for IVDR has passed, the EU-authorized representatives are still not equipped to meet the demand of all devices applying to get certified. As such, only the class A devices that do not need notified body’s approval must be CE marked and compliant with EU market standards, and the manufacturer must ready associated documents.
For all other IVDs, there is still a chance. For example, suppose the device has been certified under IVDD, and the CE certificate is valid (under IVDD). In that case, it can be marketed until product testing can be done and the notified body assessment is complete. This condition is mentioned in the IVDR article 110 and can alter in the future. So, if you were rushing to get certified, do not hold your pace on our account!
How to get your CE mark under IVDR?
Now that you know it’s beyond the time you got started (and hopefully, most of you’ve already started), here are a few tips to keep in mind while going through the process.
Analyze the files you already have. Make a list of the documents you have and the documents you need. You can get ahead much faster if you keep the process clear and concise.
Assess where you need help. Find out which experts you do not have on your team. Instead of hiring newbies for that role, fill in the position by hiring an expert or freelance the work to a group of experts who already know what they are doing.
Make sure you have enough resources available for your dossier preparation activities. So, get the tests and the analyses you need in place first.
Check if you need to make changes in your manufacturing process or the product design. Some new regulations are in place, and your hardware should be up to date to start manufacturing as soon as you get certified.
Start on parts of the Performance Evaluation Report as fast as you can. If you have a good literature review and state-of-the-art section done, it should get you a head start on the Scientific Validity Report (SVR).
You will also need to have Post-Marketing Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) plans. If you have other MDR products, you can base the plan for IVDR on them.
