CE Marking for Medical Devices under EU MDR 2017/745

CE Marking for Medical Devices under EU MDR 2017/745

The CE marking indicates conformity with the applicable EU law and is a requirement for all medical devices sold in the European Economic Area (EEA). According to Regulation (EU) 2017/745 (MDR), CE marking is a declaration of conformity made by the manufacturer. It not only guarantees that the medical device is safe but also that it can be placed on the single EU market. The CE marking indicates that the manufacturer complied with the relevant conformity obligations set out in the regulation, such as risk management, clinical evaluation, and technical documentation.

Why Did The Requirement To Get Ce Marking Change: MDR VS MDD

Before the MDR came into force, the legal basis for CE marking was the Medical Device Directive (MDD). However, the MDD was rather soft and did not regulate post market surveillance or clinical evaluation of the devices well. Regulation (EU) 2017/745 made significant updates, such as increased the importance of clinical evidence, stricter controls of Notified Bodies, and mandatory introduction of post market surveillance systems. The main difference between the MDR and MDD is that the former provides a more complete and detailed legal framework. The latter had too broad wording, thus being open to various interpretations. The MDR defines medical devices more broadly, including certain aesthetic devices. In addition, it makes it obligatory to implement all rules in all EU Member States. Such reforms were made due to safety concerns and new technologies.

Step By Step: How To Get CE Marking Under MDR

Step 1: Confirmation of Medical Device and Classification

To get a CE marking, first of all, you should make sure that the product qualifies as a medical device. You can find this information in Article 2 of the MDR. In case the product is a medical device, then you will need to classify it according to its intended purpose and associated risks described in Annex VIII. There are four classes of devices (Classes I, IIa, IIb, and III), each of which requires different steps to be taken during approval. Classification is important to understand the further procedure correctly.

Step 2: Determination of Legal Obligations

After the classification, you will need to define what regulatory requirements the device should comply with. These include the General Safety and Performance Requirements, labeling and language rules, clinical evaluation (Article 61), UDI requirements (Article 27), and conformity assessment route (Article 52). According to certain characteristics, your device may need to comply with additional rules from other pieces of EU legislation such as REACH, RoHS, or EMF. Compliance should cover all aspects of the product and its process of manufacture.

Step 3: Introduction of Quality Management System (QMS)

Quality management system is one of the core elements of the CE marking. The Article 10 requires a manufacturer to have a quality management system which guarantees conformity at each step of the device life cycle. The QMS should include production control, clinical evaluation, post market surveillance, complaint handling, and corrective actions. Additionally, the manufacturer is obliged to appoint a Person Responsible for Regulatory Compliance who meets the qualification criteria described in Article 15. For devices requiring the Notified Body control, the QMS must be certified.

Step 4: Preparation of Technical Documentation

Technical documentation is a part of the evidence of conformity. According to Annexes II and III, the technical documentation must include a description and intended use of the device, its design and manufacturing specifications, results of risk management and clinical evidence. In addition, it should include production details, labeling samples, UDI codes, and PMS/PMCF plans. The technical documentation should be readily available for Notified Bodies and Competent Authorities and must be updated regularly.

Step 5: Conducting Clinical Evaluation

The clinical evaluation is the systematized procedure for assessing and verifying the safety and performance of a medical device. As it is stated in Article 61 and Annex XIV, all devices must pass through this procedure, which might include clinical investigation, literature review, or equivalence data. Clinical investigations are obligatory for Class III and implantable devices unless there are some exemptions from the rule. Clinical evaluation must be conducted systematically and based on evidence and updated through PMCF activities.

Step 6: Conformity Assessment

The conformity assessment route is defined according to the class of the medical device. Class I devices pass through a self assessment procedure, whereas Classes IIa, IIb, and III are assessed by Notified Body. The conformity assessment includes QMS audit, technical documentation review, and maybe product testing. Conformity assessment routes include Annex IX (full QMS audit), Annex X (type examination) and Annex XI (product conformity verification).

Step 7: Issuing the EU Declaration of Conformity

Upon completing conformity assessment, the manufacturer must draft the EU Declaration of Conformity according to Annex IV. This declaration is a legally binding document which confirms the conformity of the device with all applicable MDR requirements. The declaration should contain such information as the name and address of the manufacturer, the Unique Device Identification Device Identifier, applicable standards or Conformity Specifications, and references to the conformity assessment procedures. The declaration should be signed and updated regularly and be available to Competent Authorities.

Step 8: CE Marking

Finally, you will need to put a CE mark on the device itself, its sterile packing, and on any user instruction in accordance with Article 20 and Annex V. If a Notified Body was involved in the process of assessing the device, its four digit identification number should be included in the CE marking as well. The CE mark must be clear, readable, and durable. It indicates that the device complies with MDR and can be sold in the EU. Misusing CE marking is prohibited.

Responsibilities After CE Marking

Post Market Surveillance (PMS)

Manufacturers have an obligation to monitor their devices post marketing. The process entails gathering, analyzing, and using performance data to determine whether any corrective or preventive actions are required. Article 83 makes it mandatory for a PMS system to form part of the QMS and should be proportionate to the risk of the device. Data obtained from PMS should help in risk management, labeling update, and clinical evaluation.

Post Market Clinical Follow Up (PMCF)

It entails an ongoing activity complementing the clinical evaluation of the device. Here, clinical data are actively gathered from post market use to verify that the device is safe and performs well. As Annex XIV Part B of MDR requires, it is a compulsory activity for most of the devices and especially high risk devices.

Vigilance & Incident Reporting

Manufacturers should report serious incidents, deficiencies, and field safety corrective actions to competent authorities within the stipulated period. Articles 87 to 89 provide details concerning the vigilance activities to be undertaken. Manufacturers should report any serious threats in two days and other reportable incidents within ten days.

Labeling and Unique Device Identification (UDI)

Correct labeling of products plays a critical role in making them traceable and ensuring their proper use. According to Article 27 and Annex I Section 23 of the MDR, labeling should contain information such as the unique device identification (UDI), manufacturer's name, warnings, and symbols. A device should always be labeled in the official language of the target country. UDI of a device is provided under Article 27 and Annex VI of the MDR.

What Does the CE Mark Really Mean?

CE mark represents a manufacturer's declaration of compliance to all the applicable requirements under the Medical Devices Regulation 2017/745 (MDR). Some of these requirements include design control, risk management, clinical evaluation, labeling, and post market responsibilities. CE mark ensures market access for the products within the European Union market.

Examples of CE Mark Use under MDR

• Class I Devices: Devices such as surgical gloves and bandages, where manufacturers self declare conformity in line with MDR requirements.

• Class IIa Devices: Dental filling; devices that undergo assessment and conformity approval from the Notified Body.

• Class III Devices: High risk devices such as heart valve implants that undergo comprehensive clinical investigations and in depth review by the Notified Body.

Conclusion

Getting the CE mark is a very organized process involving legal, technical, and quality assurance activities. The implementation of MDR has made the bar of compliance higher than ever. Therefore, manufacturers are expected to invest in good internal systems. Getting a CE mark is not a one time exercise.

How Morulaa Can Help

Morulaa HealthTech assists international manufacturers of medical devices in overcoming the hurdle of navigating regulatory systems with its extensive assistance in the registration, importing and post registration process for products in India and other important markets. Morulaa has an innovative independent license holder structure which allows companies to partner with several distributors while avoiding multiple registrations.