In the EU, CE marking is the system used to demonstrate that products meet the region’s requirements for safety, health, and environmental protection. When a product is labeled with the CE marking, it can be freely traded in the European Economic Area (EEA) without restrictions. 

Different types of products have different requirements for obtaining CE marking. For medical devices, manufacturers with new and re-certifying products are subject to Regulation (EU) 2017/745, also known as the EU Medical Device Regulation, or MDR. For manufacturers that are new to CE marking under the MDR, the first step is to gain an understanding of the requirements for obtaining CE marking for medical devices.

MDR CE Marking Process

Because obtaining a CE marking for a medical device allows it to be freely traded in the EEA, the process for ensuring it meets the requirements for patient safety is rigorous. This is a brief overview of the steps you can expect to take when securing a CE marking for your device.

Classify your device 

Under MDR, a medical device is classified according to its risk profile following the 22 classification rules in Annex 8. The classification does not follow a decision tree and does not depend on finding predicate devices, as in some other markets. Instead, classifications are primarily based on the device’s intended purpose. It’s also important to know that the definition of medical devices extends to all technologies, including software. This is a critical first step because the device classification informs the regulatory requirements and approval path you must follow.

Designate a person responsible for compliance (PRRC)

All manufacturers that market medical devices in the EU must designate a PRRC, as defined by Article 15 in MDR. The role of this employee is to ensure that the product conforms with quality system management, technical documentation is maintained, post-market surveillance obligations are met, and reports are prepared as required.

The designated employee must have regulatory experience, which is defined as either formal qualification in a relevant scientific discipline with at least one year of relevant experience with medical devices, or four years of relevant medical device experience. In the case of the PRRC, the relevant experience must be with quality management systems or regulatory affairs for medical devices.

Implement a quality management system

In order to obtain a CE marking, medical device manufacturers and critical suppliers must comply with EN ISO 13485, which is the quality management standard accepted by notified bodies under MDR. To stay in compliance, certification must be renewed every year.

Prepare suppliers for audits

Suppliers must be prepared for unannounced notified body audits to ensure that they are in compliance with MDR. Prepare your suppliers by performing mock audits to identify and address weaknesses.

Prepare technical documentation

MDR Annex I, II, and III require technical documentation to include:

  • Device specification, including the intended purpose/use and principles of method/operation
  • An overview of previous and similar generations of the device
  • General safety and performance requirements (GSPR) and supporting evidence
  • Risk/benefit analysis
  • Risk management file and risk/benefit analysis (ISO 14971:2019 compliance)
  • Verification and validation testing reports 
  • Clinical evaluation plan and report (CEP/CER)
  • Post-market surveillance plan (PMS) 
  • Post-market clinical follow-up plan (PMCF)  
  • Updated labeling, including instructions for use and translations
  • Manufacturing information 
  • Declaration of conformity

The technical file must also meet certain administrative requirements, so it is important to ensure you meet those before submitting to the notified body or it could result in a delay.

Appoint an authorized representative

For manufacturers that are not established in the EU, an authorized representative is required to obtain CE marking. Also known as an EC REP, this entity must be located in the EU and acts as the main point of contact between the manufacturer, notified body, and national competent authorities. Contact information for your authorized representative must be displayed on your labeling, IFU, or outer packaging. You must also obtain a single registration number for use by the manufacturer, authorized representative, and importer.

Submit to notified body review

Your technical documentation and quality management system must be audited by a notified body. This process includes a review of the technical file and up to three rounds of questions. Because each round of questions requires an investment of resources, the better you are prepared with the first submission, the faster and more cost-effective the process will be. When approved, you will receive a European CE Marking Certificate for your device that is good for up to five years and you can:

  • Prepare a declaration of conformity
  • Affix your CE marking
  • Register your device and unique device identifier (UDI) in EUDAMED

Maintain your CE marking

Maintaining your CE marking requires submitting to routine notified body audits and keeping your technical documentation in compliance. You must also perform clinical evaluation, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) activities to maintain certification.

Challenges with CE Marking Under MDR

Manufacturers that are familiar with CE marking under MDD may face some challenges staying compliant under MDR. For example, more stringent post-market surveillance requirements necessitate integrating data from multiple systems, including PMS, PMCF, and risk management. Maintaining compliance also means implementing systems to keep technical documentation updated so files are always audit-ready. Manufacturers with multiple product lines might also find it difficult to prioritize submissions based on factors such as revenue, product life cycle, the time required for submissions, and business goals.  

How RQM+ Helps

RQM+ has developed finely honed best practices for compiling technical documentation that will pass notified body review with minimal questions. We have experts in every area—clinical, regulatory, quality, and risk management—and experience across all device classes. We also have former notified body leadership on staff so we are uniquely positioned to meet reviewer expectations.

If you have multiple product lines and are not sure where to focus your efforts first, RQM+ provides risk-balanced solutions for portfolio planning based on your business objectives. Once the best path forward has been identified, our team of expert implementers can handle initial submissions and maintenance so you can focus on new product development and other priorities.

If you would like to learn more about our CE marking services for medical devices and how we can add value to your business, contact us today to schedule a consultation.

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

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