As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and efficacy but also facilitates compliance with regulatory requirements.
Top 7 Key Strategies for optimizing Post-Market Surveillance
Here, we outline key strategies for optimizing post-market surveillance in alignment with EU MDR standards.
1. Early Integration of Post-Market Surveillance into Quality Management
Integrate post-market surveillance activities into your quality management system (QMS) from the outset of product development. By incorporating PMS processes early, you establish a solid foundation for ongoing monitoring and compliance with EU MDR requirements.
This proactive approach mitigates risks and facilitates timely identification and resolution of issues in the post-market phase.
Establish comprehensive post-market monitoring protocols to systematically collect, analyze, and respond to data related to device performance, adverse events, and customer feedback.
Regularly review and update these protocols to align with evolving regulatory guidelines and industry best practices. By conducting thorough post-market monitoring, you demonstrate a commitment to patient safety and regulatory compliance.
3. Leverage Purpose-Built Tools for PMS
Utilize specialized software solutions designed for medical device surveillance and post-market monitoring. These tools offer features such as complaint handling, nonconformance management, and CAPA processes tailored to EU MDR requirements.
By leveraging purpose-built tools, you streamline PMS workflows, enhance data accuracy, and ensure compliance with regulatory standards.
4. Foster Cross-Functional Collaboration
Promote cross-functional collaboration and communication across departments involved in post-market surveillance, including regulatory affairs, quality assurance, and product development.
Establish clear channels for reporting and escalating issues, facilitating timely decision-making and corrective actions. By fostering a collaborative culture, you enhance transparency and accountability in PMS activities.
5. Ensure Compliance with Post-Market Requirements
Stay informed and up-to-date on the latest post-market requirements outlined in EU MDR legislation. Regularly review guidance documents and regulatory updates issued by competent authorities to ensure compliance with reporting obligations, vigilance requirements, and post-market clinical follow-up (PMCF) obligations.
By maintaining compliance with post-market requirements, you mitigate regulatory risks and uphold patient safety standards.
6. Enhance Data Traceability and Documentation
Maintain comprehensive traceability of post-market surveillance activities through robust documentation and data management practices. Implement systems for documenting complaints, adverse events, corrective actions, and other PMS-related information in accordance with EU MDR documentation requirements.
By enhancing data traceability, you facilitate regulatory inspections and demonstrate compliance with post-market obligations.
7. Embrace Continuous Improvement
Embrace a culture of continuous improvement in post-market surveillance processes, leveraging data-driven insights to drive enhancements and optimizations.
Regularly assess the effectiveness of PMS activities, identify areas for improvement, and implement corrective measures as needed. By prioritizing continuous improvement, you demonstrate a commitment to excellence in post-market surveillance and patient safety.
In conclusion, staying vigilant in post-market surveillance under EU MDR requires proactive planning, robust monitoring protocols, and a commitment to compliance with regulatory requirements.
By integrating PMS into quality management systems, leveraging purpose-built tools, fostering cross-functional collaboration, and embracing continuous improvement, medical device manufacturers can navigate the complexities of post-market surveillance with confidence and ensure ongoing regulatory compliance.
A Quality Management System is defined by ISO 13485 as a set of processes, procedures, and responsibilities for achieving quality policies and objectives in a medical device manufacturing organisation. It is a structured system that ensures that medical devices consistently meet customer and regulatory requirements.
ISO 13485 is an international standard that specifies requirements for a QMS specific to the medical device industry. ISO 13485 is a stand-alone QMS standard based on ISO 9001:2008, superseded by ISO 9001:2015.
It covers the design, development, production, storage, distribution, installation, servicing, and final decommissioning of medical devices.
Implementing a QMS based on ISO 13485 helps organisations demonstrate their ability to provide medical devices and related services that meet customer expectations and regulatory requirements, fostering customer confidence and regulatory compliance.
One of the critical advantages of ISO 13485 is that it ensures a strong starting point if a manufacturer wants to certify their products under the EU Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR).
MDR requirements for QMS
EU MDR states the requirement for a well-established and maintained QMS in Article 10 (9).
Article 10 of the Medical Device Regulation (MDR) outlines a set of criteria governing Quality Management Systems (QMS) for Manufacturers operating in the medical device sector.
This article mandates that manufacturers establish, document, implement, maintain, update, and enhance a QMS that aligns with MDR specifications. Furthermore, it stipulates that the QMS must be aligned with the risk classification, the nature of the device and the business.
Article 10 specifies several fundamental aspects that the QMS must address at a minimum, which are as follows:
A strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system.
Identification of applicable general safety and performance requirements and exploration of options to address those requirements.
Responsibility of the management.
Resource management, including selection and control of suppliers and sub-contractors.
Risk management is set out in Section 3 of Annex I.
clinical evaluation by Article 61 and Annex XIV, including PMCF.
Product realisation, including planning, design, development, production, and service provision.
Verify the UDI assignments made by Article 27(3) to all relevant devices and ensure the consistency and validity of the information provided by Article 29.
Setting up, implementing and maintaining a post-market surveillance system in accordance with Article 83.
Handling communication with competent authorities, notified bodies, other economic operators, customers and other stakeholders.
Processes for reporting serious incidents and field safety corrective actions in the context of vigilance.
Management of corrective and preventive actions and verification of their effectiveness.
Processes for monitoring and measurement of output, data analysis and product improvement.
This list of minimum requirements highlights that the Quality Management System necessitates a documented procedure for all significant activities directly associated with individual medical devices, along with broader processes about the company’s overall operations.
The EU MDR does not impose specific requirements for a QMS. However, manufacturers are responsible for implementing appropriate content tailored to the risk class and organisational nature.
How do you implement a QMS that actually works?
Manufacturers can utilise harmonised standards, such as ISO, to aid in implementing MDR requirements. Compliance with recognised harmonised standards, like ISO 13485:2016 for Quality Management Systems, establishes a presumption of conformity with relevant aspects of the MDR.
ISO 13485 provides detailed provisions for developing QMSs that align with most MDR quality management requirements.
Manufacturers must, therefore, ensure that a system compliant with both ISO standards and the MDR requirements outlined in Article 10 is in place to address the comprehensive demands of quality management in the medical device industry.
A manufacturer’s quality management system will be assessed as part of the conformity assessment procedures outlined in MDR Annex IX to XI. Conformity assessment for Class Ir, Is, a Notified Body will carry out Im, IIa, IIb and III devices.
Formal evaluation and certification by a notified body are not conducted for Class I devices, but the QMS requirements still apply.
Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations.
Paragraph 3 Amendments
Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that outline conditions and timelines for the placement of medical devices on the market or into service.
Let’s delve into the details of these Regulation (EU) 2017/746 amendments:
3a. Derogation and Conditions
By derogation from Article 5, devices falling under paragraphs 3b and 3c may be placed on the market or put into service, subject to the fulfilment of conditions specified in paragraph 3d.
3b. Placing Devices with Certificates
Devices with certificates issued under Directive 90/385/EEC or Directive 93/42/EEC, valid by virtue of paragraph 2, can be placed on the market until specific dates:
– Until 31 December 2027 for class III devices and class IIb implantable devices (excluding specific items).
– Until 31 December 2028 for class IIb devices (excluding those covered by the previous point), class IIa devices, and class I devices in sterile condition or with a measuring function.
3c. Conformity Assessment Procedure
Devices with conformity assessment procedures under Directive 93/42/EEC, not involving a notified body, may be placed on the market or put into service until 31 December 2028, provided certain conditions are met.
3d. Conditions for Placement
Devices can be placed on the market until the specified dates (3b and 3c) if the following conditions are met by 26 May 2024:
– Continued compliance with relevant directives.
– No significant changes in design and intended purpose.
– No unacceptable risk to health or safety.
– Implementation of a quality management system by the manufacturer.
– Lodgement of a formal application for conformity assessment by 26 May 2024 and a written agreement signed with a notified body by 26 September 2024.
3e. Application of MDR Requirements
In derogation from paragraph 3a, devices in paragraphs 3b and 3c are subject to MDR requirements for post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices.
3f. Responsibilities of Notified Bodies
The notified body issuing the certificate in paragraph 3b remains responsible for surveillance unless agreed otherwise. A transition of surveillance responsibilities is outlined in agreements between manufacturers and notified bodies.
3g. Derogation for Class III Custom-made Implantable Devices
Class III custom-made implantable devices can be placed on the market until 26 May 2026 without a certificate, provided a formal application is lodged by 26 May 2024, and a written agreement with a notified body is signed by 26 September 2024.
Paragraph 4 Replacement
Paragraph 4 stipulates that device lawfully placed on the market before 26 May 2021, and those placed afterward under paragraphs 3a, 3b, 3c, and 3g, may continue to be made available or put into service.
Article 122 Amendments
Article 122 outlines amendments related to the repeal of Directives 90/385/EEC and 93/42/EEC, effective from 26 May 2021. Noteworthy points include the continuation of Directives’ application for devices in specific paragraphs of Article 120(3a) to (3f) and (4).
Article 123 Amendments
In Article 123(3), point (d), the amendment includes a reference to Article 120(3e), further emphasizing the continued application of certain requirements from the repealed Directives.
Regulation (EU) 2017/746 Amendments
The amendments to Regulation (EU) 2017/746, also known as the In Vitro Diagnostic Devices Regulation (IVDR), focus on Articles 110 and 112.
Article 110 Amendment
Devices lawfully placed on the market under Directive 98/79/EC before 26 May 2022, and those placed afterward under paragraph 3 of this Article, may continue to be made available or put into service.
Article 112 Amendment
For devices referred to in Article 110(3) and (4) of the IVDR, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs.
Conclusion
The recent amendments to MDR and IVDR introduce a complex framework of conditions and timelines for the placement of medical devices on the market. Stakeholders, including manufacturers and notified bodies, must carefully navigate these provisions to ensure compliance and a smooth transition to the new regulatory landscape.
Under certain conditions, the UK MDR 2002 mandates that you notify the MHRA at the time of your device’s initial sale in Northern Ireland. The manufacturer’s location, the Authorised Representative’s location, and the device class determine the specific criteria.
Requirements for Non-UK manufacturers
To sell medical equipment in Northern Ireland, non-UK manufacturers are exempt from the requirement to designate a UK Responsible Person.
To sell devices in Northern Ireland, manufacturers who are based outside of the EU or the EU must designate an Authorised Representative who is based in the EU or in Northern Ireland.
Requirements for Great Britain-based manufacturers placing devices on the Northern Ireland market
To place a device in Northern Ireland, British manufacturers must choose an Authorised Representative with a base in the EU or Northern Ireland.
Where an EU-based Authorised Representative is appointed, the manufacturer located in Great Britain is required to register with the MHRA all device classes other than Class I devices and general IVDs (those are not for self-testing)
Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative must register all devices with the MHRA.
How can importers register?
When a product is placed on the Northern Ireland market, the Authorised Representative headquartered in Northern Ireland is required to give the MHRA information on the person doing so if they are not:
The manufacturer, or
The Northern Ireland-based Authorised Representative.
How to do the registration of custom-made devices in Northern Ireland?
On the EU market (including Northern Ireland), only devices that are custom-made in accordance with EU MDR 2017/745 are permitted.
Before May 26, 2021, custom-made devices registered under the EU MDD or EU AIMDD and sold in an EU member state other than Northern Ireland may still be registered with MHRA with the intention of being sold exclusively in Northern Ireland.
What are the details needed to register your device with the MHRA?
You are asked to provide the following information when registering your devices
Manufacturer details:
legal entity name and address as it appears on the device labelling/packaging
company type e.g., limited company, sole trader
administrative contact (you can have up to 15 people with access)
a designation letter (if any) for UK Responsible Persons. This must be a formal contract that identifies you as the manufacturer’s sole UK Responsible Person and outlines the duties you are required to perform under the terms of the agreement. Our regulatory guidance for UK Responsible Persons contains the necessary responsibilities that need to be included in the designation contract.
In the intricate landscape of medical device regulations, successfully bringing products to market requires a thorough understanding of the varying requirements in different regions.
This market access guide provides comprehensive insights into the European Union (EU), Switzerland, and the United Kingdom (UK) regulations, shedding light on crucial aspects such as Authorized Representatives, Importers, and other economic operators.
Crafting your Marketing Strategy
A well-defined marketing strategy is the foundation for entering any market. It is essential to carefully consider the products you wish to sell and the targeted regions. While the instinct might be to reach every corner, strategic planning helps avoid unnecessary costs.
Post-Brexit, the complexity has increased, necessitating separate Authorized Representatives and Importers for each region.
Understanding Economic Operators
Authorized Representatives
In the EU, a manufacturer outside the region must appoint an Authorized Representative.
The Authorized Representative, prominently identified on product labels, shoulders responsibilities such as verifying EU conformity, registration obligations, and cooperation with competent authorities.
EU MDR Article 11: Key Responsibilities of Authorized Representatives
Verify the EU declaration of conformity and technical documentation.
Keep copies of technical documentation and the EU declaration of conformity.
Comply with registration obligations.
Provide information to demonstrate device conformity.
Forward requests from competent authorities to the manufacturer.
Cooperate on preventive or corrective actions.
Immediately inform the manufacturer about complaints and suspected incidents.
Terminate the mandate if the manufacturer acts contrary to obligations.
Importers
Importers situated within the EU play a pivotal role in ensuring products’ adherence to regulations before entering the market. They verify CE marking, proper labelling, and other compliance criteria.
Significantly, they are obliged to keep meticulous records and promptly address non-compliance concerns.
EU MDR Article 13: Duties of Importers
Place on the market only devices in conformity with the regulation.
Verify CE marking, EU declaration of conformity, and manufacturer’s identification.
Ensure proper labeling and instructions for use.
Verify UDI assignment by the manufacturer.
Maintain a register of complaints, non-conforming devices, recalls, and withdrawals.
Cooperate with authorities on corrective actions.
Inform the manufacturer and authorities about non-compliance and serious risks.
The European Market
EU MDR 2017/745 and IVDR 2017/746
For medical devices and in-vitro diagnostics, compliance with EU MDR and IVDR is paramount. Manufacturers must meticulously follow the regulatory requirements outlined in these legislations.
Initiating with Article 10 and ensuring conformity with EU standards is the cornerstone.
EU MDR Article 10: General Obligations of Manufacturers
Verify compliance with legislation, specifically EU MDR or IVDR Article 10.
Comply with the requirements of EU MDR or IVDR Article 10 for economic operators.
Provide necessary information to authorized representatives and importers.
Authorized Representative
The EU Authorized Representative must be well-versed in EU MDR and IVDR requirements. The role encompasses tasks from verifying documentation to cooperating with authorities.
Transparency is critical, with the Authorized Representative’s details prominently displayed on product labels.
Importer
Importers act as the last line of defence before products hit the market. As per Article 13, their verification processes ensure that only compliant devices enter the EU.
The importer’s role includes handling complaints, cooperating with competent authorities, and maintaining a comprehensive register.
EUDAMED Registration
EUDAMED, the European Database for Medical Devices, plays a pivotal role in the regulatory landscape. Manufacturers, Authorized Representatives, Importers, and other entities must register in EUDAMED to obtain the Single Registration Number (SRN).
This digital hub facilitates information exchange, ensuring transparency and traceability.
EUDAMED Registration Process
EUDAMED, the European Database for Medical Devices, is pivotal for transparent information exchange among stakeholders. The registration process involves:
1. Identify your Role
Determine if you’re a Manufacturer, Authorized Representative, or Importer, each with unique responsibilities.
2. Access EUDAMED
Create an account on the user-friendly EUDAMED platform
3. Provide Details
Enter essential company information and specify your role.
4. Verification
Undergo a verification process to confirm the legitimacy
5. Get SRN
Receive a Single Registration Number (SRN) upon successful verification.
6. Maintain Compliance
Regularly update the information to stay compliant.
7. Information Exchange
Utilize EUDAMED for efficient information exchange with authorities and stakeholders. This streamlined process ensures regulatory compliance and facilitates seamless interaction within the EU’s medical device landscape.
Switzerland
Post-Brexit
Switzerland, no longer part of the Mutual Recognition Agreement, mandates manufacturers outside the EU to appoint Authorized Representatives and Importers within Switzerland. The regulations mirror EU MDR and IVDR, emphasizing compliance.
Differences in Switzerland
While Switzerland aligns closely with EU regulations, distinctions exist. The CH-REP symbol stands in for the EC REP symbol, and a unique registration process, distinct from EUDAMED, adds a layer of complexity.
UK Market Access: Navigating the Post-Brexit Scenario
The UK Responsible Person
Post-Brexit, the UK Responsible Person assumes a role akin to the EU Authorized Representative. The UK MDR 2002 sets out responsibilities, emphasizing conformity checks, complaint management, and immediate reporting of non-compliance.
UK MDR 2002 Responsibilities of the UK Responsible Person
Ensure the declaration of conformity and technical documentation are in order.
Keep copies of technical documentation and the declaration of conformity.
Provide information to demonstrate device conformity to the MHRA.
Cooperate with the MHRA on preventive or corrective actions.
Immediately inform the manufacturer about complaints and suspected incidents.
Terminate the legal relationship if the manufacturer acts contrary to obligations.
Symbolic Absence
Unlike the EU, the UK lacks a designated symbol for the Responsible Person. The absence prompts a textual mention on labels. Notably, this requirement applies to UKCA-marked products post-Brexit.
Conclusion
Navigating the regulatory landscape for medical devices demands a nuanced understanding of region-specific requirements.
From strategic marketing planning to compliance with EU, Swiss, and UK regulations, this guide provides a detailed roadmap for manufacturers aiming to ensure seamless market access while embracing the intricacies of post-Brexit realities.
EUDAMED is a pivotal component, serving as the digital nexus for regulatory information exchange, ensuring compliance and traceability.
