The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in the European Union. For manufacturers of higher-risk devices (Class IIa, Class IIb, and Class III), involving a notified body in the conformity assessment process is mandatory; however, most manufacturers of Class I devices have the option to self-certify their medical devices.
In this article, we review self-certification and what it means for medical device manufacturers in the European Union. We also take a look at the self-certification process and some of the difficulties you will come across if attempting self-certification.
EU Certification and CE marking
To put your medical device on the market in the European Union, you need your device to go through a conformity assessment and become certified to carry the CE mark. The CE mark is the little “CE” we have all seen on products that are manufactured in, or imported from, the European Union. The CE mark demonstrates that your device conforms with the current regulation and is considered safe and efficient enough to be placed on the European market.
The CE marking requirements, i.e. the steps needed to affix the CE marking to your product, as defined by the European Commission, are:
- Identify the applicable directive(s) and harmonized standards
- Verify product-specific requirements
- Identify whether an independent conformity assessment (by a notified body) is necessary
- Test the product and check its conformity
- Draw up and keep available the required technical documentation
- Affix the CE marking and draw up the EU Declaration of Conformity
For higher-risk devices, i.e. Class IIa, Class IIb, and Class III, the conformity assessment must be handled by a notified body.
Does my product classify for self-certification?
The first step in determining whether your medical device can be self-certified to CE marking is to determine its classification. The classification of a medical device depends on the intended use and risk class. Obviously, devices that, by their nature, are riskier to use will be higher classed than devices that are almost or entirely risk-free.
Most Class I medical devices that are not provided sterile and do not have a measuring function do not require notified body conformity assessment and can be self-certified. As a side note, most Class A in vitro diagnostic medical devices (IVDs) can also be self-certified, if they are not provided sterile.
While it sounds simple enough to self-certify your product, the European MDR is renowned for being complex to understand and work with. Unless your regulatory staff is highly experienced in EU legislation and CE marking directives, we recommend hiring an external regulatory consultant to confirm your classification and whether or not your device classifies for self-certification.
Now that you have your device classification confirmed and you want to proceed with self-certification, let’s take a look at the self-certification process. While it might seem overwhelming, it is not actually that complicated when you get down to the details, as long as you follow the process set up by the European Commission.
Steps 1-3: Identification of directives and general requirements for safety and performance
The first step of self-certification is identifying the applicable directives, which is quite simple for medical devices as these are encompassed in the EU MDR. Problems arise for devices on the border of the medical device definition. However, since you already confirmed your medical device status and classification before starting the self-certification process, we are good to go!
The essential requirements for medical devices are specified in Annex I of the EU MDR: General Safety and Performance Requirements (GSPRs). To achieve conformity assessment, you need to identify which GSPRs your medical device must comply with. This should be fairly obvious for most Class I devices.
Step 4: Conformity assessment
This is where you test your device to all the applicable requirements and standards. Performance testing should include tests to comply with both safety requirements and performance requirements. Tests should be carried out in accordance with harmonized standards, such as ISO or IEC.
Step 5: Technical documentation
Even when self-certifying, you should still elaborate on a technical file. The technical file includes all the technical documentation gathered for your device during the design and development and verification and validation phases.
Your technical file should include intended use, device description, material lists, diagrams, specifications, test reports, and declarations of conformity. Declarations of conformity can be provided for both the materials included in the device and the finished device itself.
Step 6: Declaration of conformity and CE marking
Once you have completed all the steps and you are satisfied with your product tests and your technical file has been completed, you can draft your EU declaration of conformity.
The declaration of conformity is described in Annex IV of the MDR. The regulation describes the different elements the declaration of conformity must include:
- Registered name, trademark, and address of the manufacturer and their authorized representative, if applicable
- A statement that the declaration of conformity is issued under the sole responsibility of the manufacturer
- Product identifiers, such as trade name, product code, catalog number, etc.
- A statement declaring that the device is in conformity with the MDR and any other relevant European Union legislation
- Place and date of issue of the declaration, as well as information about the person signing (name, function, company, etc.)
Now that your declaration of conformity is ready the only pending step is adding the CE mark to your product! Annex V of the MDR describes the design-specific features of the CE mark and how it should be reproduced.
Note that several countries in the EU require further registration with their National Authorities to be able to import and commercialize CE marked products. Your CE-marked product should also be registered in EUDAMED.
Even though self-certification sounds easier than going through conformity assessment with a notified body, the path to CE marking is complex. You will have to understand and define the legislative structure surrounding your medical device and identify and perform the appropriate tests required for your specific product. Even just understanding which General Requirements for Safety and Performance (GSPRs) your device must comply with can be tricky.
However, it is a great option for any Class I medical device manufacturers who have a firm grasp of the European regulation and can put it in the context of their medical device and its characteristics. And of course, hiring an external consulting company or freelancer can improve the self-certification process and the final product. External aid can also greatly lessen the time required of internal regulatory and quality staff, as well as the pain felt by everyone involved.