Ensuring Compliance with EU Medical Device Regulation (MDR)

At Medical Devices and Pharma, we provide expert regulatory consulting services tailored to the medical device and pharmaceutical industries. Our team of specialists guides you through the complex landscape of EU MDR compliance, ensuring that your products meet all necessary standards and regulations.

Compliance with the EU’s 2017 Medical Device Regulation (MDR) requires a series of detailed and ongoing activities for medical device manufacturers.  

Medical Devices and Pharma can guide you through the key MDR compliance activities. 

Classification of Devices 

Determine Classification. Establish the correct classification for each device according to the MDR rules, which are more stringent than previous regulations. 

Quality Management System (QMS) 

Implement or Update QMS. Develop or update a Quality Management System compliant with ISO 13485:2016. 

Regular Audits. Conduct regular internal and external audits to ensure QMS effectiveness. 

Technical Documentation 

Compile Technical Files. Prepare comprehensive technical documentation for each device, detailing its design, manufacturing, and intended use. 

Clinical Evaluation Report (CER). Conduct and document clinical evaluations to provide evidence of the device’s safety and performance. 

Risk Management 

Risk Assessment. Perform thorough risk assessments and implement risk management plans throughout the device lifecycle as per ISO 14971. 

Conformity Assessment 

Select Conformity Assessment Procedure. Choose the appropriate conformity assessment route, which may involve notified bodies. 

Engage with Notified Bodies. Collaborate with notified bodies for audits and assessments, ensuring compliance with MDR requirements. 

Labeling and UDI (Unique Device Identification) 

Update Labels and Instructions for Use. Ensure that all labeling, packaging, and instructions for use comply with MDR requirements. 

Implement UDI System. Assign and implement UDI codes for traceability. 

Post-Market Surveillance (PMS) 

Develop PMS Plan. Establish and maintain a post-market surveillance plan to monitor device performance and safety after it is placed on the market. 

Vigilance Reporting. Implement systems for reporting adverse events and incidents to the appropriate authorities. 

Registration and EUDAMED 

Register Devices and Economic Operators. Register devices and relevant economic operators (manufacturers, importers, etc.) in the EUDAMED database. 

Maintain EUDAMED Records. Keep EUDAMED records up to date with any changes to devices or economic operators. 

Clinical Investigations 

Plan and Conduct Clinical Investigations. If necessary, plan and carry out clinical investigations in compliance with MDR requirements. 

Supplier and Subcontractor Management 

Assess and Manage Suppliers. Evaluate and manage suppliers and subcontractors to ensure they meet MDR requirements. 

Documentation and Record Keeping 

Maintain Comprehensive Records. Keep thorough and accessible records of all compliance activities, technical documentation, PMS, and other relevant documents. 

Training and Competence 

Staff Training. Ensure that all staff are adequately trained on MDR requirements and updates. 

Maintain Competence. Keep training records and continually update staff competence. 

Market Access and Distribution 

Ensure Market Compliance. Verify that devices meet MDR requirements before entering the EU market. 

Monitor Distribution Channels. Keep track of distribution channels to ensure continued compliance. 

Periodic Safety Update Reports (PSURs) 

Prepare PSURs. For certain classes of devices, compile and submit PSURs as part of the post-market surveillance process. 

Environmental and Regulatory Changes 

Stay Updated. Monitor changes in the regulatory environment and adapt compliance strategies accordingly. 

Summary 

By addressing these activities, medical device manufacturers can align with the stringent requirements of the EU MDR, ensuring their devices are safe, effective, and legally marketed within the European Union.