What are the levels of the CE standard for medical devices?

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The European Union (EU) has defined the required regulation for the field of medical Devices through 3 directives: EEC AIMDD, IVDD, MDD. On May 26, 2021, The Directives have merged into the new Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), to ensure a high level of patient safety. The Union Standards System is classified according to the risk levels of product use. Depending on the level of classification, the process for obtaining a CE standard for medical devices is defined.

The new regulation has come about to strengthen the weak links and resolve the issues that have been identified since the application of the Directives in the late 1990s', mainly in three areas: new technologies (such as medical- aesthetics products, software, etc.), traceability of events and developments and public transparency.

What are the new regulation's Principles?

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• High-risk products are required to face much stricter quality control and audit.

• A new system for approving and supervising Notified Bodies.

• Clear procedures for the certification process (frequency of each test, audit plan, explicit content).

• Inclusion of products without a medical purpose.

• New classification rules

• Transparency of information to the general public.

• Evaluation of up-to-date clinical information (for all types of medical devices - also Class I).

• NEW obligations on importers and distributors located in Europe

• Designation of the person responsible for the regulation in the country of manufacture (PRRC).

• Collaborations between health authorities.

 

What should you do in order to be prepared for the NEW requirements?

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STEP 1 | Classification
To comply with the new requirements, manufacturers must first establish the classification of their devices according to the new classification rules and act accordingly. It is important to note that there are products that are currently at a low-risk level (Class I) but might become a medium-risk level (IIa) or high-risk level (Class III) under the new regulation. For example, software or surgical gloves are currently classified today as Class I, but they will be classified as Class IIa or III (!) under the new rule.
 
STEP 2 | Identification
Manufacturers must figure out what the new regulation means regarding product approval and what is relevant to your specific Device. It is advisable to run a gap analysis to update the technical portfolio, quality system, evaluation, and clinical plan. Even address cases where there is an overlap between the new regulation MDR and other regulations, such as the GDPR.
 
STEP 3 | Technical Documentation
Once we have mapped the requirements, understood the classification, coordinated expectations with the notified body or an authorized representative in the EU – we can start modifying the technical documentation (Technical File) and quality management system (although the manufacturer is required to present a quality management system under the new regulation, the recommendation is to apply ISO 13485:2016 version, mainly since it's the acceptable standard for quality system management, but also because it is "best" evidence to show compliance with the quality management system requirements.

For more information about the Technical Documentation stages click here

STEP 4 | Notified Body & Authorized Representative
Once all these have been compiled and reviewed, the manufacturer must contact a Notified Body and a European Authorized Representative to certify the medical Device under the MDR and complete the EUDAMED registration.
 
STEP 5 | CE Marking & EUDAMED
One of the main objectives of the MDR was to offer transparency to the general public. To this end, a European database EUDAMED (European Database of Medical Device) has been set up, into which data will be entered regularly. This will include clinical data, clinical investigations, incidents, and reports. In addition, the manufacturer is required to submit to the authorities an annual report detailing the manufacturer's activity and the medical Device PSUR (= Periodic safety update reports) to increase transparency.

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There is no doubt that the transition between the existing directives and the new regulation may prove revolutionary, although there are still some unanswered questions. The EU is determined to meet the set deadlines and bring the new regulation into effect in May 2021.

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