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.
OMC Medical Set to Attend KIMES, Invites Participants to Meet at UK Pavilion for Uninterrupted Market Access Solutions
SEOUL, SOUTH KOREA – February 21, 2024 – OMC Medical, a leading provider of regulatory support and market access solutions for medical device, cosmetics, and pharmaceutical manufacturers, announces its participation in the Korea International Medical & Hospital Equipment Show (KIMES) from March 14 to March 17, 2024. The event, one of the largest medical exhibitions in Asia, will be held at COEX in Seoul, South Korea.
OMC Medical extends a warm invitation to all KIMES attendees to visit their booth at the UK Pavilion, where they will showcase their comprehensive range of services aimed at facilitating global market entry for manufacturers in the medical industry.
KIMES is a crucial platform for professionals and organizations within the medical sector to explore the latest innovations, network with industry peers, and foster collaborations. This year’s event promises to bring together a diverse array of participants, including medical professionals, researchers, manufacturers, and regulatory experts, all eager to stay abreast of advancements in healthcare technology.
Attending KIMES presents an invaluable opportunity for stakeholders to gain insights into emerging trends and regulatory requirements shaping the global medical market. Moreover, it offers a conducive environment for forging strategic partnerships and expanding business horizons.
OMC Medical specializes in assisting medical device, cosmetics, and pharmaceutical manufacturers in navigating the complex landscape of local regulatory processes worldwide. By serving as their trusted local representative or authorized representative, OMC ensures seamless compliance with regulatory standards, thus enabling uninterrupted market access.
Unlike traditional distributor models, which often entail frequent changes and license instability, OMC Medical offers a stable and reliable partnership, empowering manufacturers to maintain consistent revenue streams and overcome the challenges associated with market access disruptions.
At KIMES 2024, OMC Medical will be on hand to demonstrate how their tailored solutions can streamline the market entry process, mitigate regulatory risks, and maximize business opportunities for participants across the globe.
For more information about OMC Medical and their participation in KIMES 2024, please visit https://www.omcmedical.com or contact their team directly at [email protected]
Implanted medical devices, from life-saving pacemakers to pain-relieving joint replacements, are transforming how we manage health conditions. However, carrying these technological marvels within our bodies presents a unique challenge: readily accessing critical information about them when seeking medical care. This is where the power of implant ID cards comes into play.
Think of these cards as miniature medical passports, discreetly holding a wealth of knowledge about your implants. They typically store essential details such as the device name, type, unique identification number, manufacturer information, implantation date, and even the name of the implanting physician. This seemingly simple card becomes a powerful tool, empowering you to navigate the healthcare system confidently and efficiently.
Why are implant ID cards so invaluable?
There are various benefits of implant ID Cards, these are:
1. Peace of mind and empowerment
No more scrambling to recall intricate details during doctor’s appointments or stressful emergencies. The card readily equips you with the information healthcare professionals need, fostering a sense of control and ownership over your health journey.
2. Faster, more accurate care
Imagine arriving at a new clinic and having your complete implant history instantly available. This eliminates time-consuming information gathering, minimizing the risk of errors and delays in treatment. Your doctor can quickly assess any potential interactions with your implants and tailor treatment plans accordingly.
3. Enhanced emergency preparedness
Every second counts when facing critical situations. Implant ID cards provide life-saving information to first responders and medical teams, ensuring immediate compatibility with essential equipment and procedures. This difference can be between a swift response and a potentially life-threatening delay.
4. Simplified monitoring and maintenance
Certain implant types require ongoing monitoring and potential adjustments. The card facilitates smooth communication between you and your healthcare providers, enabling proactive management of your implant’s performance and optimizing long-term outcomes. You can receive timely alerts about potential issues and easily schedule necessary adjustments.
5. Building a connected healthcare landscape
Beyond individual benefits, implant ID cards contribute to a more interconnected and collaborative healthcare system. Their standardized format enables seamless data exchange between hospitals, clinics, and even across national borders.
This paves the way for personalized care pathways, remote monitoring capabilities, and improved overall communication within the healthcare network.
So, how can you access this valuable tool? If you have an implanted medical device, simply ask your doctor for an implant ID card. Most hospitals and clinics now routinely issue them to their patients. You can also find more information and resources on the websites of relevant national health organizations or international bodies like the European Commission.
Conclusion
In conclusion, implant ID cards are not merely passive information carriers; they are powerful enablers for a smoother, safer, and more personalized healthcare experience. As their adoption grows, they hold the potential to revolutionize the way we manage medical implants, empower patients, streamline healthcare systems, and ultimately build a brighter future for all.
The Saudi Arabian Medical device registration and approval is governed by the Saudi Food and Drug Authority, also known as the SFDA. The procedure for the introduction of a medical device in the Saudi Arabian market is called Medical Device Marketing Authorization (MDMA).
SFDA has published a guidance document, MDS-REQ-001, on Requirements for Medical Device Marketing Authorization. This guidance provides detailed information on the authorization process.
Saudi Arabian Medical Device Classification
SFDA classifies medical devices into four classes: Class A, B, C & D. Medical device classification is done as per Annex 5 of MDS-REQ-001. The medical devices are classified based on 22 rules, while the in-vitro diagnostic devices are classified based on seven rules.
Any foreign manufacturer willing to market their product in the Kingdom of Saudi Arabia (KSA) must appoint a Saudi Arabia Authorized Representative (AR). This AR will carry out all the registration formalities on behalf of the legal manufacturer.
The AR must possess an Authorized Representative License to conduct the registration activities effectively.
What is GHAD System?
The SFDA has switched to an electronic system for document submission, called GHAD System. Local and Foreign manufacturers, via an AR, should submit their application electronically in the GHAD System.
The manufacturer shall prepare a Technical Documentation, comply with and confirm the Essential Principles of Safety and Performance and maintain an effective Quality Management System (QMS).
4 Components of Saudi Arabian Technical Documentation
Other essential components of Saudi Arabian Technical Documentation will include:
1. Device Description & Specification
2. Labels and IFUs
3. Risk Management File
4. Post Market Surveillance documents
SFDA can request more information if needed which should be provided to them within ten days of request.
In addition to the above-mentioned documents, clinical evaluation is another important documentation in the Technical File. Adequate clinical evaluation studies should be carried out to prove the safety and efficacy of the medical device.
Performance evaluation studies should be carried out demonstrating scientific validity, and clinical and analytical performance. A strong clinical evaluation report, plan, and post-market clinical follow-up should support the technical file.
Post Market Surveillance
Post Market Surveillance Report is required to be submitted by manufacturers of Class A devices. This report should be generated when necessary or when requested by the SFDA. Manufacturers of Class B, C and D devices should generate a Periodic Safety Update Report (PSUR).
A PSUR should be generated annually for Class C and D devices and once every two years for Class B devices. Class D and Implantable devices should produce Summary of Safety and Clinical Performance documentation.
The SFDA also accepts electronic Instructions for Use (e-IFU). The manufacturers should provide adequate risk assessment documentation related to the e-IFU. The risk assessment should be updated in conjunction with the post-marketing activities.
For devices with a fixed expiry date, the e-IFU should be maintained for at least two years after the end of the expiry date of the last produced device. For devices with no expiry, the e-IFU should be maintained for 15 years after the previous device has been manufactured.
About OMC Medical
OMC Medical is primarily based in the UK with offices around the globe offering regulatory support to medical device manufacturers; Offering assistance starting from medical device design requirements in accordance to the relevant applicable standards, obtain relevant MoH certification or listings, establishing your devices in a new market, keep product licenses up to date until the product is End of Service (EOS).
