An Overview:
The CE mark signifies that the product you are holding has been tested and certified to meet European Economic Area safety, health, and environmental requirements. The European Economic Area (EEA) is made up of the European Union’s (EU) member countries as well as a few other European countries that are not nominal EU members.
The most important thing to understand for our purposes is that every medical device, even those with the lowest risk, needs a CE label to be sold in the EEA. As a CE mark medical device expert, we address this difficulty efficiently.
Even if you do not live in the European Economic Area, the CE label will appear on many of the products you purchase because they must be marketed in the EEA. If you wish to fast-track your medical equipment into the EU market. you need to know the answers to three questions typically asked by medical device manufacturers before you begin the process of gaining that CE marking:
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1. What Is the Purpose of a CE Marking for Medical Devices?
Everyone wants to be sure that the items they use daily are both safe and effective. And for some product categories, such as medical devices, the stakes are too high to leave anything to chance. That is why a CE marking is required, as well as the procedure for obtaining one.
CE stands for “Conformité Européene” (which translates to “European Conformity”) and signifies that the product has been evaluated by its maker and determined to comply with all applicable EU criteria.
Keep in mind that the CE marking serves as a certification by the manufacturer that their product complies with all applicable regulatory standards. While the manufacturer is technically responsible for disclosing the conformance of their product, this does not mean that the European Commission is not enforcing its own rules.
Before obtaining a CE marking for their equipment, most medical device manufacturers would need to have their quality management system (QMS) evaluated by an independent notified body (NB). A notified body is a private entity to whom an EU member state has delegated competence to assess medical devices’ compliance with all applicable regulatory standards.
Consumers should trust that a product satisfies high health, safety, and environmental requirements once it has completed its certification audit, declared compliance, and attached its CE marking.
2. What Are the Steps /The Process for Obtaining a CE Marking?
While “CE” isn’t a quality mark, adherence to the EU Medical Devices Regulation (MDR 2017/745) necessitates meeting precise standards of performance, quality, safety, and efficacy tailored to your product type. Operon Strategist’s comprehensive guide outlines the current European CE approval process for medical devices. Nonetheless, the fundamental procedure for obtaining a CE mark for medical devices typically involves the following steps:
- Determine if your product aligns with the definition of a medical device as outlined in the EU MDR.
- Determine the medical device classification in Europe for your medical devices.
- Implement a Quality Management System (QMS) if it applies to your device. Many companies utilize ISO 13485 to fulfill these requirements.
- Prepare a CE Marking Technical File or a Design Dossier.
- Compile a Clinical Evaluation Report (CER) following the guidelines of MEDDEV 2.7/1 rev4 and the MDR.
- Select and designate a European Authorized Representative (EC REP) to act on your behalf within the EU if you lack a physical presence in Europe.
- Subject your QMS and Technical File/Design Dossier to an audit by a Notified Body, unless your device falls under Class I, is non-sterile, and lacks a measuring function.
- Obtain CE certificate for medical devices and ISO 13485 certificates from your designated Notified Body.
- Prepare a EU Declaration of Conformity (DoC) confirming that your device complies with the regulations outlined in the MDR.
3. What Are the Requirements of My QMS to Obtain a CE Marking?
The MDR is clear: medical device makers must have a quality management system in place, and it must meet certain basic standards, as described in Article 10 of the MDR, ‘General obligations of manufacturers.’
The 12 QMS requirements as per MDR:
- A Strategy for regulatory compliance, which includes procedures for conformity assessment and management of modification to the device.
- Identification and exploration of safety and performance requirements
- Resource management
- Risk management
- Clinical evaluation
- Product realization, which includes design, development, production, and service
- Verification of Unique Device Identity (UDI) assignments
- Creation and maintenance of a post-market surveillance system
- Communication with authorities notified bodies, and other stakeholders
- Process for serious incidents
- Management of CAPAs (corrective and preventive actions) and verification of effectiveness.
- Processes for monitoring and measuring output, data analysis, and product improvements.
ISO 13485:2016, fortunately, covers all of these standards. While the MDR does not require manufacturers to apply ISO 13485, it is the only QMS standard that has been added to the EU’s list of standards that are being considered for harmonization.
To put it another way, using ISO 13485:2016 to ensure you satisfy the MDR standards for quality management systems is strongly recommended.
Using outdated QMS solutions might be risky during notified body audits, especially when the CE marking is in trouble. With extensive knowledge as medical device regulatory consultants, we have overseen various projects and given critical training and direction for ensuring strong QMS compliance. For expert guidance, connect with us today.
