Executive Summary
PMS is a regulatory requirement that systematically monitors a medical device's safety, performance, and quality once it enters the market. PMS processes allow manufacturers to collect real-world data, assess device efficacy, and ensure long-term compliance with regulatory standards. QNET, as your Authorized representative in the EU, UK, and Switzerland, has an important role in informing manufacturers to meet PMS requirements.
2. PMS Requirements by Region
European Union (EU)
The EU's Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746 mandate that manufacturers implement a PMS system that integrates with their Quality Management System (QMS). Essential PMS requirements include:
- PMS Plan: A detailed plan tailored to each device's risk classification, covering data collection, analysis, and corrective actions as necessary.
- PMS Report (PMSR): Required for Class I devices, providing regular updates on device safety, performance, and any corrective actions taken.
- Periodic Safety Update Report (PSUR): Required for Class IIa, IIb, and III devices, the PSUR includes annual or biennial updates on benefit-risk assessments and post-market clinical follow-up (PMCF).
- Notified Body Oversight: High-risk devices require notified body audits, but all devices are subject to PMS requirements to ensure compliance.
United Kingdom (UK)
Post-Brexit, the UK enforces similar PMS requirements under the UK MDR, but manufacturers must navigate specific UK processes:
- UKRP Requirement: Non-UK manufacturers who designate QNET as UKRP to manage PMS responsibilities, ensure compliance with national PMS standards, and facilitate communication with MHRA.
- Incident Reporting: The UKRP ensures that adverse events and safety issues are promptly reported to MHRA in alignment with UK regulations.
Switzerland
Switzerland aligns closely with EU MDR requirements. It enforces unique PMS processes through Swissmedic:
- Swiss Ordinance on Medical Devices: Manufacturers must submit a PMS plan and regularly collect safety and performance data, especially for Class I devices that often lack notified body oversight.
- Swissmedic Inspections: Swissmedic conducts targeted inspections, ensuring compliance with PMS requirements and mandating corrective actions as necessary.
3. Role of National Competent Authorities
National competent authorities enforce PMS compliance, using targeted inspections and regulatory action to ensure manufacturers uphold safety and quality standards.
Swissmedic (Switzerland)
- Class I Device Inspections: Swissmedic inspects Class I devices to confirm compliance with the Swiss Ordinance, requiring evidence of systematic PMS. Non-compliant manufacturers may face market restrictions until corrective actions are implemented.
- Data Transparency: The upcoming Swissdamed database will improve oversight by centralizing data on devices marketed in Switzerland.
IGJ (Dutch Competent Authority)
- PMS Framework: The IGJ monitors compliance with PMS requirements under MDR and IVDR, strongly focusing on SMEs and legacy devices. The IGJ encourages manufacturers to proactively address compliance gaps and use PMS data for device improvements.
MHRA (United Kingdom)
- Vigilance and Incident Reporting: MHRA emphasizes prompt incident reporting and maintains strict PMS documentation requirements. The UKRP supports non-UK manufacturers in fulfilling these responsibilities by managing regulatory interactions with MHRA.
4. Specific Roles of Authorized Representatives in PMS Compliance
EU Authorized Representative (EAR) / QNET
- Primary Responsibilities: QNET, as the EAR, is the official regulatory liaison between non-EU manufacturers and the EU authorities. Responsibilities include verifying the manufacturer's PMS plan, ensuring compliance with MDR requirements, and facilitating vigilance reporting to the relevant authorities.
- PMS Documentation and Audits: QNET, as the EAR, provide support in maintain and update PMS documentation, such as PSURs and PMSRs, and prepares the manufacturer for possible audits by national authorities. QNET also supports that PMS outcomes are applied to the QMS, helping the manufacturer address and document corrective actions.
- Risk Mitigation: By coordinating communication with EU competent authorities, QNET helps mitigate regulatory risks, keeping the manufacturer informed of PMS requirements and updates within the EU.
UK Responsible Person (UKRP)
- Role as a Regulatory Contact: QNET, as the UKRP, acts as the primary regulatory contact for non-UK manufacturers, ensuring compliance with the UK MDR and maintaining the required PMS documentation. QNET, as the UKRP, must be readily available to MHRA and address all regulatory issues related to the device, particularly safety and performance concerns.
- Incident Reporting and Vigilance: QNET, as the UKRP, is responsible for reporting any adverse events or safety concerns involving the device to MHRA. QNET can coordinate closely with the manufacturer to facilitate prompt and accurate incident reporting, as well as to ensure that the PMS data remains up-to-date.
- Integration with QMS: QNET, as the UKRP, assists the manufacturer in integrating PMS findings into their QMS and implementing any necessary design or labeling updates based on PMS outcomes. They also ensure that PMS requirements adapt to any regulatory changes in the UK, such as the implementation of new guidelines.
Swiss Representative (CH-REP)
- Liaison with Swissmedic: QNET, as CH-REP, supports non-Swiss manufacturers in meeting Switzerland's PMS requirements, including device registration with Swissmedic and ensuring accurate, up-to-date PMS documentation. QNET is responsible for notifying Swissmedic of safety issues or trends and facilitating communication on regulatory matters.
- PMS Documentation and Compliance Checks: QNET, as CH-REP, ensures the manufacturer maintains comprehensive PMS documentation, including PMS plans, reports, and incident data. QNET assist in fulfilling Swissmedic's data transparency initiatives and ensure PMS findings are integrated with other QMS elements, such as risk management and performance evaluations.
- Corrective and Preventive Actions: Swissmedic expects the CH-REP to support the manufacturer in implementing corrective actions identified during PMS. By coordinating with Swissmedic, QNET, as CH-REP, helps the manufacturer demonstrate compliance and avoid regulatory action, such as market restrictions.
5. Practical Considerations for Manufacturers
- Addressing PMS Complexity: National competent authorities emphasize that PMS is a complex requirement, and smaller manufacturers may face challenges in managing it effectively. Through EAR, UKRP, and CH-REP services, we help manufacturers build a robust PMS system that aligns with EU, UK, and Swiss regulations.
- Strategic Benefits of Authorized Representatives: Our EAR, UKRP, and CH-REP services provide essential support, ensuring that manufacturers adhere to PMS requirements while maintaining their focus on device innovation and quality.
Conclusion
PMS is a fundamental regulatory requirement, essential to device safety and public health. The roles of national competent authorities, including Swissmedic, IGJ, and MHRA, highlight the need for robust PMS practices, especially for manufacturers based outside the EU, UK, and Switzerland. By partnering with us as your EU Authorized Representative, UK Responsible Person, and Swiss Representative, manufacturers can navigate PMS requirements with confidence, knowing they have trusted regulatory support across all regions.
PMS Activities, Milestones, Time Windows, Market-Specific Requirements, and QNET’s Role
|
Activity |
Milestone |
Time Window |
Market-Specific Requirement |
MRM/QNET’s Role |
|
Preparation of PMS Plan EU MDR Annex III, Section 1.1; IVDR Annex III, Section 1.1 |
Submit the finalized PMS Plan to the relevant regulatory authority |
Within 3 months of device market entry |
Swissmedic requires PMS plans for Class I devices; MHRA aligns with vigilance requirements. |
Assist in preparing and reviewing PMS Plans to ensure regulatory compliance across markets. Submit to Swissmedic for Class I devices. |
|
Initial PMS Report/PSUR Preparation EU MDR Article 85; Article 86; IVDR Article 79 |
Complete and submit the first PMS Report/PSUR |
12 months after market entry |
Swissmedic may audit Class I PMS documentation; UK PSUR requirements may vary under transitional provisions. |
Draft, review, and finalize PMS Reports and PSURs. Coordinate submission to relevant authorities (notified bodies, MHRA, Swissmedic). |
|
Periodic PMS Reports for Class I Devices EU MDR Article 85 |
Submit updated PMS Reports |
Annually (or as defined in the PMS Plan) |
UK Class I devices must align with MHRA vigilance; Swissmedic may request updates for audits. |
Support in compiling annual PMS reports. Act as EAR/UKRP/CH-REP to facilitate compliance with national authorities. |
|
PSUR for Class IIa, IIb, III Devices EU MDR Article 86; IVDR Article 81 |
Submit updated PSUR to the notified body (if applicable) |
Annually for Class III; Biennially for IIa, IIb |
UK: Submit PSUR to MHRA. Switzerland: Swissmedic may request PSUR for Class I devices. |
Compile and submit PSURs for high-risk devices. Act as the liaison for notified bodies, MHRA, and Swissmedic. |
|
PMCF/PMPF Plan Preparation EU MDR Annex XIV, Part B; IVDR Annex XIII, Part B |
Finalize PMCF/PMPF Plan |
Concurrent with the PMS Plan submission |
Swissmedic requires PMCF plans for high-risk and borderline Class I devices. |
Draft PMCF and PMPF Plans tailored to device and market requirements. Submit as needed to MHRA and Swissmedic. |
|
PMCF/PMPF Activities EU MDR Annex XIV, Part B; IVDR Annex XIII, Part B |
Complete post-market studies or literature reviews |
As outlined in the PMCF/PMPF Plan |
MHRA requires study authorization for PMCF involving significant risks. |
Coordinate PMCF/PMPF activities, including study planning, monitoring, and reporting. Liaise with authorities for approvals. |
|
PMCF/PMPF Report Preparation EU MDR Article 61(10); IVDR Article 56(10) |
Submit PMCF/PMPF Report |
Within 6 months of PMCF/PMPF study completion |
Switzerland: Align PMCF/PMPF reports with Swissmedic oversight framework. |
Prepare PMCF/PMPF reports. Submit reports to Swissmedic and MHRA, and notify bodies as required. |
|
Trend Analysis and Risk Evaluation EU MDR Article 83; IVDR Article 78 |
Perform detailed trend analysis on PMS data |
Every 6 months (or as defined in the PMS Plan) |
UK: Align trend analysis with MHRA reporting thresholds. |
Support in analyzing PMS data for trends. Provide regulatory advice on addressing identified risks. |
|
Corrective/Preventive Actions (CAPAs) EU MDR Article 83(3); IVDR Article 78(3) |
Implement CAPAs based on PMS findings |
Immediately upon identification of risks |
Swissmedic requires detailed CAPA documentation for Class I devices. |
Assist in documenting CAPAs and communicating implementation progress to authorities. |
|
Technical Documentation Updates EU MDR Annex II; IVDR Annex II |
Update Risk Management File, Clinical/Performance Evaluation |
Within 3 months of PMS/PSUR/PMCF findings |
Swissmedic emphasizes regular updates for Class I devices. UK requires alignment with MHRA post-Brexit guidance. |
Review and update technical files to reflect PMS findings. Ensure alignment with QMS and regulatory expectations. |
|
Incident Reporting EU MDR Article 87; IVDR Article 82; UK MDR Part 5 |
Submit serious incident reports to authorities (e.g., MHRA) |
Within 2 days of awareness (serious incidents) |
UK: MHRA requires reporting of non-serious incidents for trend analysis. |
Submit incident reports to MHRA, Swissmedic, or EU competent authorities. Act as a contact point for follow-up actions. |
|
Periodic QMS Review EU MDR Article 10(9); IVDR Article 10(8) |
Incorporate PMS findings into QMS updates |
Annually or as part of Management Review |
Swissmedic requires PMS integration in SME QMS. UK: Reflect PMS findings in QMS updates for MHRA reviews. |
Support manufacturers in integrating PMS outcomes into QMS and preparing for regulatory audits. |
|
Regulatory Authority Communication EU MDR Article 87; UK MDR Part 5; Swiss Ordinance, Article 59 |
Provide updates or respond to queries from authorities |
Within specified deadlines (varies by authority) |
UK: MHRA expects timely updates. Switzerland: Swissmedic requires immediate CAPA responses. |
Act as the main point of contact with competent authorities. Respond to queries and facilitate compliance on the manufacturer’s behalf. |
Key Takeaways
- Unified Compliance Strategy: QNET ensures all PMS activities meet MDR, IVDR, UK MDR, and Swissmedic requirements, reducing the complexity for manufacturers.
- Representation Across Regions:
- As EAR, QNET manages PMS submissions and compliance in the EU.
- As UKRP, QNET ensures alignment with MHRA’s reporting and vigilance requirements.
- As CH-REP, QNET facilitates Swissmedic communications and supports enhanced PMS oversight for Class I devices.
- Expert Support at Every Step: From PMS Plan development to CAPA implementation and incident reporting, QNET provides comprehensive assistance to ensure manufacturers meet their regulatory obligations.