MDR Consulting

MDR Compliance Doesn’t Have to Be Complicated

Work with our consultants to obtain ISO 13485, implement management system controls, and set your medical device manufacturing business up for success in Europe.

Medical Device Regulation or CE Marking for Medical Devices

To sell medical devices in Europe, manufacturers must obtain a CE mark, which signifies that their device meets safety and effectiveness requirements. This requirement also applies to in-vitro medical devices and active implantable medical devices, which have their own separate legislative directive but follow similar rules.

In Europe, medical devices are categorized into different classifications based on their level of risk, similar to the FDA classifications in the US. Less risky devices fall under Class 1, which has fewer requirements and does not require an audit or review. More risky devices, such as Class 3 (with Class 2a and 2b in between), have more stringent requirements, including a comprehensive product master file, design review, and independent auditing of management system requirements.

Your Compliance Journey Begins Here

Achieving compliance with the Medical Device Regulation (MDR) starts with obtaining certification in ISO 13485. While ISO 13485 is not mandatory in the legislation, it is widely accepted as the solution for meeting quality management requirements. By obtaining ISO 13485 certification audited by an approved certification body (Notified Body), you fulfill an essential part of the legislation. The legislation also requires additional management system controls, such as post-market surveillance, vigilance, and reporting.

Technical Requirements for Increased Safety

The legislation includes technical requirements that necessitate comprehensive records for medical devices. This includes clinical and other testing, as well as stability testing for devices with electronics or electrical components to prove resistance to radiated and conducted interference. Risk assessments on the device and certain production processes are also required, with detailed evidence to support compliance with the Essential Requirements outlined in the legislation. If international or national standards exist for the product or relevant processes (e.g., sterilization, toxicity testing), adherence to these standards is expected. Harmonized standards, which are mandatory, cannot be disputed.

It is important to note that while FDA requirements and CE marking are separate, they essentially demand the same outcome. The approach to demonstrating compliance should be unified, utilizing one system, one set of processes, and one set of records wherever possible. Some separate evidence may be necessary (e.g., ISO 13485 versus CFR21 Pt. 820), and some duplication may be required to present the information differently to different agencies, but the overall goal is to have one system in place.

Why Cavendish Scott Does it Different

With decades of experience, Cavendish Scott helps organizations navigate these complex requirements. While we cannot vouch for the safety and efficacy of the products themselves, we understand the regulatory requirements and can assist in implementing management system processes to ensure compliance. We provide checklists, formats, and file structures to help you compile the necessary technical information for your device. We excel at challenging the content of your files, ensuring comprehensive and effective documentation for review by the notified body. Our expertise and experience minimize delays and costly mistakes, offering a cost-effective and value-added solution to your regulatory requirements. We approach our services in a business-focused yet disciplined manner and provide ongoing support to ensure ongoing compliance.