Gaining access to the European market with your medical device is a cause for celebration, but comes with regulatory mandates. One of the most critical is gaining ce marking for medical devices, which will prove that your product complies with the health and safety and performance requirements specified by the European Union (EU).
Without this labeling, medical devices are not able to be sold in the European Union or the European Economic Area (EEA). For many it can be difficult to know where to start with the CE mark process, in particular since it is still very disorganised with MDR 2017/745. This site offers a detailed walkthrough of the process so that those wanting to enter the American market can do so with confidence.
What Is A CE Mark And Why Does It Matter in Europe?
It states the product is CE marked for compliance with European regulations. In the case of medical devices, it indicates that the manufacturer has completed the requisite conformity assessments and demonstrated that the product is safe for its intended use and has the intended performance characteristics.
The CE mark isn’t merely a ho-hum regulatory process, it’s a ticket to the European marketplace. Upon applying it to your product, it permits the free market movement of your device within the EU and acceptance in many non-EU nations.
If a product does not carry a CE mark, authorities may decide to order product recalls, ban imports or even bring legal action. For makers who want to lend tracks an air of legitimacy and win over medical personnel and their patients, the CE mark is a must-have.
Step 1: Know the Laws
In Europe, the legislation governing medical devices is now the Medical Device Regulation (MDR 2017/745), not the previous Medical Device Directive (MDD). MDR tightened the requirements, in particular on clinical evidence, post market surveillance and technical documentation.
It is for the manufacturers to decide initially whether the product falls within the MDR definition of a medical device. “in that event” (meaning, if so, then such requirements must have been met before manufacturers will be able to apply for CE marking).
Key considerations include:
Clinical indication and manufacturer’s intended use of the device (Class I, IIa, IIb or III)
Particular (harmonised) standards (ISO 13485, ISO 14971, IEC 62366, etc.) are applicable.
Post-market clinical evaluation and monitoring needs
Step 2: Device Classification
Classifying of device is one of the most important steps when it comes to the CE-marking process. There are four classes of medical devices, which are classified according to their level of risk.
Class I – Low risk (e.g. stethoscopes, bandages)
Class IIa – Medium risk (for example, hearing aids, dental fillings)
Class IIb – High risk (for example, ventilators, infusion pumps)
Class III – Implants, cardiovascular devices, placing recipient in unreasonable risk of adverse health effect.
The classification dictates the degree of regulatory oversight, and reliance on a Notified Body (NB). Self-declaration is permitted for Class I non-sterile and non-measuring devices. All other classes require a Notified Body to verify compliance.
Step 3:Establish and maintain a Quality System
To show this, one needs a good Quality Management System (QMS). The majority apply ISO 13485:2016, the most familiar standard to medical device QMS.
The QMS should cover:
Design and development controls
Management of risk processes (corresponding to ISO 14971)
Supplier management and traceability
Complaint handling and corrective actions
Post-market surveillance procedures
Implementing a QMS not only helps with CE marking, but also creates trust and long-term relationships with healthcare providers.
Step 4: Conduct a Clinical Assessment!
Assess the patient’s vaccination status The next step in the MMRV VZV vaccine decision is step 4, in which you conduct a clinical assessment to determine the best course of action.
MDR is heavily evidence-based. Manufacturers have to demonstrate that the device will be able to carry out the claims for which it’s been intended, and it doesn’t contain anything that’s dirty or dangerous. This is accomplished via a Clinical Evaluation Report (CER), which can be supported by:
- Literature reviews of similar devices
- Clinical investigation data
- Post-market clinical follow-up (PMCF) results
For higher-risk devices, the performance of clinical studies in compliance with ISO 14155 is generally required. The CER should be maintained up-to-date as more product safety and performance data is accrued.
Step 5: Prepare Technical Documentation
Manufacturers are required to prepare a Technical File or Design Dossier containing specific elements regarding the device:
- Device description and intended use
- Design and manufacturing processes
- Risk management reports
- Biocompatibility, electrical safety and usability trials
- Clinical evaluation and performance data
- Labeling and instructions for use
This is the ‘paperwork’ required for the conformity assessment that will be scrutinised by the Notified Body (where applicable).
Step 6: Cooperate with Notified Bodies
For Class IIa, IIb and III devices, the Notified Body is very important. These are independent entities appointed by EU authorities to review medical devices for compliance.
The Notified Body will:
- Review technical documentation
- Audit the manufacturer’s QMS
- Conduct product testing (if required)
- Upon successful completion, a CE certificate will be issued.
The selection of the Notified Body is so important, the knowledge, the timing of response to you can make a big difference in your approval.
Step 7: Affix the CE Mark
After conformance is established, and the Notified Body has drawn up the certificate (if required), the manufacturer can place the CE mark on the device. The CE mark has to be affixed visibly, legibly and indelibly. Devices that have been reviewed by a Notified Body should also have their NB identification number in addition to the CE marking.
The product is now commercially available in the EU and EEA.
Step 8: Post-Market Surveillance
Getting CE marking doesn’t mean it is done. Manufacturers will have to keep an eye on the market’s receptivity to the device. This includes:
- Collecting and analyzing customer feedback
- Reporting a major incident using the vigilance feature
- Revisions to technical documentation and clinical evaluations
- Initiating corrective or preventive actions wherever necessary
The MDR is also all about lifecycle monitoring – and so compliance will remain an ongoing obligation.
Common Challenges in the CE Marking Process
Finally, manufacturers encounter obstacles like:
- Misclassification of devices leading to regulatory delays
- Incomplete technical documentation
- Insufficient clinical evidence
- Delays in Notified Body assessments due to high demand
It takes strategic planning, the guidance of an expert, and early action to do so. Regulatory consultants can help you through the process, and avoid costly mistakes.
How Professional Guidance Can Help
It is complex to understand MDR and CE marking requirements, which is further challenging for startups and companies who are looking to enter the EU market for the first time. This is where personal training comes in handy! Companies such as 3iconcept Medical Solution focus on regulatory consulting, design controls, and compliance services for the medical device space. Thanks to the knowledge of the industry, manufacturers will be able to reduce the risk of delays and be confident of fulfilling all CE duties. To learn more or get expert support, reach out today via our contact page or email us directly.
Final Thoughts
It’s a tough and mandatory road to retain ce marking for medical devices for companies that want to sell their products in Europe. From device categorization and QMS adoption to clinical investigation and NB review, everything needs to be accurate to be MDR compliant.
It is not easy, but with the right preparation and advisers’ help, you will get approved more easily and have success in the long run in the European market. By knowing the requirements and providing quality and safety, manufacturers can achieve more than CE marking and win the trust and credibility in an extremely competitive healthcare market.