Why CE Marking is Essential for EU Market Access
Legal background
CE Marking is a legal requirement for placing most medical devices on the EU market. It enhances your credibility, builds user confidence, and opens doors to global markets that recognize EU conformity. Whether your product is self-declared or requires third-party assessment, CE Marking demonstrates that it has been rigorously evaluated and meets the EU’s legal and technical requirements.
Failing to obtain it can lead to serious regulatory consequences:
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- Customs blocks and product recalls and administrational penalties.
- Financial losses from market delays or non-compliance penalties.
- Reputational damage from lack of trust in your product’s safety and performance.
Our services
How Obelis Supports Your CE Marking Journey
We offer full-service regulatory support to help medical device and IVD manufacturers meet the CE Marking requirements under MDR and IVDR. We assist in identifying the correct device classification, selecting the appropriate conformity assessment route, and reviewing your technical documentation to ensure it meets EU standards. For devices that require CE certification, we help coordinate the process with Notified Bodies. As your authorised representative, we handle regulatory communications, assist with EUDAMED registration, and ensure ongoing compliance with post-market surveillance and vigilance obligations.
With Obelis by your side, the CE Marking process becomes faster, clearer, and fully aligned with your device’s market access goals.
FAQ
Frequently Asked Questions
CE Marking is a mandatory conformity marking that confirms your medical device or IVDs, device complies with the EU Medical Devices Regulation (MDR 2017/745) or the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). It indicates your device meets stringent EU requirements for safety, health, and environmental protection, allowing legal sale within the European Economic Area (EEA).
CE Marking is required for products that fall under specific EU directives and regulations designed to ensure safety, health, and environmental protection. CE Marking is mandatory for all medical devices and in vitro diagnostic devices (IVDs) placed on the EU market, regardless of risk class. This includes:
- Medical devices ranging from simple bandages (Class I) to complex implantable devices (Class III)
- In vitro diagnostic devices used for medical testing
The manufacturer of the product holds the primary responsibility for CE Marking. They must ensure that the product complies with all relevant EU regulations and standards before placing it on the market. This includes conducting conformity assessments, preparing technical documentation, and affixing the CE Marking.
In some cases, other economic operators such as authorised representatives, importers and distributors also have specific obligations to verify that products bear CE Marking and comply with EU rules before they enter or circulate within the EU market.
- Determine your device classification.
- Prepare technical documentation showing compliance.
- Choose the right conformity assessment route.
- Involve a Notified Body if required.
- Implement a Quality Management System (QMS).
- Sign the EU Declaration of Conformity.
- Affix the CE Mark on your product.
- Register your device in EUDAMED.
- Maintain post-market surveillance.
