Ensuring Compliance with EU Medical Device Regulation (MDR)
Your Partner in Navigating EU MDR Requirements
Medical Devices and Pharma offers comprehensive services to help your business meet the stringent requirements of the EU Medical Device Regulation (MDR). Our expertise ensures that your products are compliant, safe, and ready for the European market.
Our Regulatory Consulting Services
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.
Our services include comprehensive regulatory strategy development, technical documentation review, clinical evaluation, and post-market surveillance. We work closely with your team to identify and address any compliance gaps, providing actionable solutions to ensure your products are market-ready.
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.
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Regulatory Documentation for National and Global Market Access
With a solid base of technical documentation, our regulatory specialists will prepare a regulatory submission that is organized, well written, complete, and meets the regulatory requirements of the agency that will evaluate the product.
Get Expert Assistance with EU MDR Compliance
Don’t navigate the complexities of EU MDR compliance alone. Contact Medical Devices and Pharma today to learn how our expert consulting services can help your business achieve and maintain compliance with ease. Let us be your trusted partner for regulatory success.