Notice
This section is currently being developed. Articles will be added regularly until this list is complete. (Last updated 14 April 2025)
| Number | Article Title |
|---|---|
| 1 | Overview of the EU MDR for Distributors |
| 1.1 | What is the EU Medical Device Regulation (EU MDR)? |
| 1.2 | Key Differences Between EU MDR and Previous Regulations (MDD) |
| 1.3 | Why the EU MDR is Crucial for Medical Device Distributors |
| 2 | Legal Responsibilities of a Medical Device Distributor |
| 2.1 | General Distributor Obligations Under the MDR |
| 2.2 | Designation of a Responsible Person (RP) |
| 2.3 | Ensuring Compliance of Products in the Market |
| 2.4 | Traceability and Record-Keeping Requirements |
| 3 | Quality Management Systems (QMS) for Distributors |
| 3.1 | The Role of QMS for Medical Device Distributors |
| 3.2 | Key Requirements for QMS Under the MDR |
| 3.3 | Documentation and Audits for Distributors |
| 4 | Post-Market Surveillance and Vigilance |
| 4.1 | Overview of Post-Market Surveillance (PMS) for Distributors |
| 4.2 | Reporting Adverse Events and Device Defects |
| 4.3 | Corrective and Preventive Actions (CAPA) |
| 4.4 | Market Surveillance by Competent Authorities |
| 5 | Responsibilities for Product Traceability and Identification |
| 5.1 | Unique Device Identification (UDI) Requirements |
| 5.2 | Labeling and Documentation Obligations |
| 5.3 | Managing Product Recalls and Field Safety Corrective Actions (FSCA) |
| 6 | Customs and Importation Requirements |
| 6.1 | Role of Distributors in Importing Medical Devices into the EU |
| 6.2 | Importer Responsibilities Under the MDR |
| 6.3 | Coordination with Manufacturers for EU Import Compliance |
| 7 | MDR for Distributors: Special Considerations |
| 7.1 | What to Do When Dealing with Non-CE Marked Products |
| 7.2 | Handling Devices Not Compliant with MDR |
| 7.3 | Dealing with Multiple Manufacturers and Third-Party Compliance |
| 8 | Regulatory Inspections and Audits |
| 8.1 | Preparing for an MDR Compliance Inspection |
| 8.2 | Common Issues Found During Audits |
| 8.3 | Responding to Non-Conformities and Enforcement Actions |
| 9 | Training and Compliance for Staff |
| 9.1 | Essential Training for Distributors on MDR Compliance |
| 9.2 | Keeping Staff Updated on MDR Amendments and Changes |
| 9.3 | Creating a Compliance Culture within Your Distribution Company |
| 10 | Penalties and Enforcement for Non-Compliance |
| 10.1 | Consequences of Non-Compliance with the MDR |
| 10.2 | Fines and Penalties for Distributors |
| 10.3 | Case Studies of Enforcement Actions in the EU |
| 11 | Impact of Brexit on MDR Compliance for UK-Based Distributors |
| 11.1 | Changes in the Regulatory Landscape Post-Brexit |
| 11.2 | What UK Distributors Need to Know About EU MDR Compliance |
| 12 | Resources for Medical Device Distributors |
| 12.1 | Useful Websites and Regulatory Bodies |
| 12.2 | MDR Compliance Checklists and Tools |
| 12.3 | Associations and Support Networks for Distributors |
| 13 | Definitions |
| 13.1 | Competent Authorities |