CE Marking Submissions

The EU regulatory process for obtaining CE marking can be complicated, particularly for foreign manufacturers.

The approval to apply the CE mark to a medical device in the EU is the result of a manufacturer’s quality management system and product-related technical data having been reviewed and deemed to meet EU health and safety requirements by a notified body. There are various pathways to achieving the CE mark approval depending on the regulation (e.g., MDR, IVDR) and device classification. Manufacturers often find themselves confused by the new regulations, associated technical standards, and complicated approval processes to achieve market access in the most efficient and timely manner.

AlvaMed can assist manufacturers with selecting which regulation is applicable for their device(s) and determining which conformity assessment route(s) are to be followed to obtain the CE mark.

Implementation of a quality management system standard, such as ISO 13485, is the basis for compliance with the EU regulations.

Preparing the technical data for devices is a critical part of regulatory compliance with the EU regulations. Identifying requirements associated with the device and assembling objective evidence for those requirements provides a foundation for safety and design.

Drawing up and signing a Declaration of Conformity (DoC) is the manufacturer’s attestation that the product complies with the applicable requirements. The DoC should accompany the product and be made available to authorities upon request.

Application of the CE mark on labelling follows very specific rules for location, size, shape, and integrity. AlvaMed can interpret these rules and guide manufacturers toward compliance.

AlvaMed has decades of knowledge and experience to assist its clients in managing the regulatory pathways through quality system and device approvals.

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CE Marking Submissions FAQ's

CE marking is not universally applicable to all products; it is primarily relevant to products covered by specific EU regulations. Businesses need to identify the relevant regulations for their specific product category to determine if CE marking is required. Selling non-compliant products may result in legal consequences and market access issues.

No. CE marking is an approval for products specific to the European Economic Area (EEA) and indicates compliance with EU regulations. It does not serve as a global certification. Other regions have their own certification and product requirements.

The duration for obtaining CE marking can vary depending on factors such as the complexity of the product, the applicable regulations, and the efficiency of the conformity assessment process. It’s essential for manufacturers to plan ahead and factor in the time required for compliance as typical time frames could be between 8-12 months depending on the availability of a notified body.

Eric Bannon

Senior Vice President of Regulatory and Clinical Affairs

Schedule a meeting with Eric to learn how AlvaMed can help navigate the regulatory process for CE approval.