CE marking is a critical prerequisite for the successful marketing of medical devices in Europe. This mandatory marking demonstrates that the product meets all applicable EU regulations and is safe for its intended use. Health technology product development nowadays requires a thorough understanding of the CE marking process from the early stages of development work, as considering regulatory requirements later can cause significant delays and costs.
The new Medical Device Regulation (MDR) has significantly tightened requirements, and companies need even deeper expertise to navigate successfully in the complex regulatory environment.
What is CE marking and why is it essential for medical devices?
CE marking (Conformité Européenne) is a statutory conformity marking that demonstrates a medical device meets all applicable EU directives and regulations. Without CE marking, a medical device may not be placed on the market in the European Economic Area. The marking is the manufacturer’s declaration that the product has been designed and manufactured in accordance with applicable requirements.
The Medical Device Regulation (MDR 2017/745) has replaced the previous directive and brought stricter requirements. Compliance requirements now cover more extensively clinical evidence, patient safety and post-market surveillance. With the MDR regulation, manufacturers must demonstrate the safety and effectiveness of their products more comprehensively throughout the entire product lifecycle. Particularly higher risk class devices require notified body assessment before CE marking.
Key stages and challenges of the CE marking process
The CE marking process begins with product risk classification, which determines the applicable requirements. Technical documentation preparation is at the core of the process and includes product design, manufacturing processes, risk management as well as clinical evaluations. Risk management implementation according to ISO 14971 standard is essential, and it covers hazard identification, risk analysis and risk reduction measures.
Clinical evaluations are particularly challenging, as they require a comprehensive literature review or conducting clinical studies. Declaration of conformity preparation requires systematic review of all applicable requirements. The role of the notified body is emphasized in higher risk devices, which require independent assessment before market placement. The most common pitfalls relate to inadequate documentation, insufficient clinical evidence and deficiencies in risk management, which can cause months of delays.
Clinipower’s expertise in the CE marking process
We have deep experience in MDR, IVDR, FDA and MDSAP regulations as well as ISO 13485, ISO 14971 and IEC 62304 standards. We support organizations throughout the entire CE marking process from technical documentation preparation to risk management implementation and quality system development. Our project model suits both large organizations and startup companies, and we can provide tailored solutions according to customers’ resources.
Our international network enables acquiring specialized expertise as needed, and our experience from both startup companies and international health technology giants ensures a versatile perspective on different organizations’ needs. Practical work experience from the health technology industry helps us identify critical development points and provide effective solutions for meeting regulatory requirements. We help our customers avoid the most common pitfalls and ensure a smooth path to CE marking.
