New ways in the MDSAP audit: From Approach 008 to 009 and the impact of the AU P0037.002
01. Oktober 2024
The Medical Device Single Audit Program (MDSAP) has become an essential tool for companies in the medical technology industry.
It enables the fulfilment of multiple regulatory requirements in different countries through a single audit. Given the ever-changing regulatory landscape, the MDSAP's requirements and procedures are continuously updated to meet current standards.
This blog post highlights the recent changes in the MDSAP audit approach from version 008 to 009 and discusses the new features of the MDSAP AU P0037.002 document. In addition, we will examine the impact of these changes on upcoming audits and existing certifications and provide valuable tips on how to avoid unnecessary deviations.
What are the changes in the MDSAP Audit Approach from 008 to 009?
The transition from version 008 to version 009 of the MDSAP audit approach brought significant changes. Two of the most important changes concern:
- Removal of references to MHLW MO16: In the new version, all references to the Japanese Ministry of Health, Labour and Social Affairs (MHLW) MO169 were removed, as this was tailored to ISO 13485:2003. The changes reflect the adaptation to the more current ISO 13485:2016. This measure is intended to ensure that the audit procedures take into account the latest international standards and focus on the most up-to-date regulatory requirements.
- Adaptation to US-508 compliance: To meet the requirements of the U.S. Section 508 of the Rehabilitation Act of 1973 (with the 1998 Amendment), coloured boxes and fonts have been removed throughout the document. This change was introduced to improve accessibility for people with disabilities. Adapting to the US-508 compliance means that MDSAP documents are accessible to a larger audience and meet digital accessibility requirements.
- Requirements for the Australian Sponsor
- What are the new features of the MDSAP AU P0037.002?
- Escalation rule in case of absence of procedures
- Conditions for the recurrence of findings
- Clarification on the relevant clauses for findings
- Supplement to the list of findings: “Context and Significance”
- What does this mean for upcoming MDSAP audits?
- What impact do these changes have on existing certifications?
- Dos and Don’ts: How to avoid unnecessary deviations?
- Allow with one audit worldwide: How MDSAP works
- Conclusion
Requirements for the Australian Sponsor
One of the most striking changes in the new version of the MDSAP audit approach concerns the country-specific guidelines for Australia (TGA). In this release, certain requirements have either been revised or completely removed. The responsibility for complying with regulatory requirements now lies explicitly with the Australian sponsor. This emphasises the role of local actors in regulatory monitoring and ensures that compliance with local regulations is strictly monitored.
What are the new features of the MDSAP AU P0037.002?
The document MDSAP AU P0037.002, which has not yet been published (as of 09. September 2024), brings with it new clarifications regarding the assessment of non-conformities. These adjustments aim to avoid misunderstandings in the application and to enable a more precise assessment of non-conformities during an audit. Although the evaluation system itself has not been fundamentally changed, the clarifications improve the standardisation of audit procedures and make the evaluation process more comprehensible for auditors and companies.
Escalation rule in case of absence of procedures
An escalation occurs when both a documented process or procedure is missing, and the requirements have not been implemented. This escalation leads to a more serious classification of non-conformity. This illustrates the importance of the implementation and documentation of all required processes. In practice, this means that companies must ensure that their formal processes not only exist on paper, but are actually applied in daily practice.
Conditions for the recurrence of findings
A finding shall be deemed to be recurring if it has been found in any audit within the last three years. Repeated findings indicate systematic problems and can have more serious consequences. This demonstrates the importance of not only implementing corrective measures, but ensuring their effectiveness in the long term. Proactive review and correction of previous findings is key to avoiding recurring non-conformities.
Clarification on the relevant clauses for findings
The MDSAP AU P0037.002 now provides clarifications on which specific clauses can be made. This transparency helps auditors and companies to accurately assess non-conformities and ensure that the findings can be clearly and clearly assigned to specific regulatory requirements. This facilitates the implementation of targeted corrective measures for companies and improves the traceability of the audit process.
Supplement to the list of findings: “Context and Significance”
A new feature of the MDSAP audit process is the introduction of an additional field in the detection list called “Context and Significance.” This field provides the authorities with more background information on the respective non-conformity and gives them the opportunity to assess the potential impact on product safety and compliance more well-founded. This supplement is particularly useful for more accurately agreeing regulatory decisions and better assessing the risk to end users.
What does this mean for upcoming MDSAP audits?
The changes described have far-reaching implications for upcoming MDSAP audits. For companies, this means they need to adjust to stricter audits and more accurate assessments. Auditors will probably pay more attention to the implementation of documented processes and in particular to whether they are also used in practice. In addition, repeated findings that indicate systematic weaknesses can lead to more serious consequences.
What impact do these changes have on existing certifications?
For existing certifications, the changes could lead to more intensive monitoring and a higher escalation of findings. Companies must ensure that their processes not only meet current requirements, but also do not show recurring problems in subsequent audits. Complete documentation and the complete implementation of all required processes are essential to meet the stricter requirements.
Dos and Don’ts: How to avoid unnecessary deviations?
- Do: Make sure that all relevant information is made available to the auditors completely and precisely. Careful and transparent preparation reduces the risk of misunderstandings and unnecessary deviations.
- Do: Make sure that all processes are not only documented, but also correctly implemented in practice. Auditors are increasingly paying attention to the implementation of documented procedures.
- Don’t: Do not rely on the fact that once implemented corrective measures are sufficient. Recurring findings can have more serious consequences, as they indicate systematic weaknesses.
- Don’t: Ignore accessibility and country-specific regulations requirements. Changes such as adapting to US-508 compliance or the Australian sponsor's increased responsibilities show that local regulations and international standards are the focus.
Allowing with an audit worldwide: How MDSAP works
MDSAP as a global standard for medical technology manufacturers
The Medical Device Single Audit Program (MDSAP) is designed to unify the international requirements for the approval of medical devices. The objective of the program is to enable medical device manufacturers to certify through a single audit for multiple markets. By participating in MDSAP, manufacturers can distribute their products in the countries involved without additional audits, which not only saves time and costs, but also increases global market availability.
The importance of MDSAP for the medical technology market
The program was developed to meet the increasing demands on product safety and quality in the field of medical technology. Given the technological advances and increasing complexity of medical devices, it is critical for regulators worldwide to enforce strict standards to ensure patient safety. MDSAP is an important step in this direction as it reduces the fragmentation of regulatory requirements in different countries while promoting high quality standards.
The biggest advantage for manufacturers is that the MDSAP covers the requirements of several countries. The countries involved in the program include the USA, Canada, Brazil, Australia and Japan. Through this cross-border acceptance of the MDSAP, manufacturers operating in several of these markets can achieve significant benefits.
Herausforderungen bei der Implementierung von MDSAP
Trotz der zahlreichen Vorteile, die MDSAP bietet, stehen viele Unternehmen vor Herausforderungen bei der Implementierung des Programms. Insbesondere kleinere Unternehmen sehen sich häufig mit der Komplexität der Anforderungen konfrontiert. Für diese Unternehmen kann die vollständige Anpassung an die MDSAP-Vorgaben eine erhebliche Investition an Zeit und Ressourcen erfordern.
Eine der größten Herausforderungen ist die Einhaltung der länderspezifischen Vorschriften. Obwohl das MDSAP mehrere Märkte abdeckt, hat jedes Land weiterhin seine eigenen spezifischen Anforderungen, die erfüllt werden müssen. Dies betrifft insbesondere Länder wie Kanada und Australien, die zusätzliche Anforderungen stellen, die über die allgemeinen MDSAP-Standards hinausgehen.
Challenges in implementing MDSAP
Despite the numerous benefits that MDSAP offers, many companies face challenges in implementing the program. Smaller companies, in particular, often face the complexity of the requirements. For these companies, full adaptation to MDSAP requirements may require a significant investment in time and resources.
One of the biggest challenges is compliance with country-specific regulations. Although the MDSAP covers several markets, each country continues to have its own specific requirements that need to be met. This applies in particular to countries such as Canada and Australia, which impose additional requirements that go beyond the general MDSAP standards.
Tips to Prepare for an MDSAP Audit
To ensure that your company is ready to meet the requirements of an MDSAP audit, consider the following steps:
- Early planning and preparation: Start preparing for the audit as early as possible. It is important that all relevant documents and processes are complete and up to date.
- Employee training: Make sure your employees are well trained and understand the requirements of the MDSAP audit. This is especially important for those who are directly involved in the quality assurance and control process.
- Working with external consultants: Consider consulting external consultants who have experience with MDSAP audits. These can provide valuable insights and support in the preparation
- Simulation of an audit: Perform an internal "mock audit" to identify potential vulnerabilities and ensure that you can meet all the requirements of the audit.
MDSAP and the future of the regulatory landscape
With the increasing acceptance of the MDSAP, the program is expected to evolve in the future and possibly expand to other countries as well. This could lead to an even greater harmonisation of global regulatory requirements, which would be a significant relief for manufacturers.
At the same time, however, it is also expected that the requirements for product safety and quality will continue to increase. Manufacturers must therefore adjust to the fact that future audits will be even stricter and more detailed. This makes it all the more important that companies are already investing in robust quality management systems and compliance programs.
Conclusion
The recent changes in the MDSAP audit process, as well as the introduction of the MDSAP AU P0037.002 document, show that the program remains up to date with regulatory requirements. For companies in the medical technology industry, this means that they must continuously adapt to new requirements and ensure that their processes meet the highest standards.
The MDSAP offers tremendous benefits for companies operating in global markets. With the right preparation, companies can ensure that they can successfully pass audits and distribute their products worldwide. Yet, despite the benefits, the challenges must not be underestimated. Careful preparation and a comprehensive understanding of the new rules are essential to avoid possible deviations and to ensure the quality and safety of medical devices.
Overall, the MDSAP is expected to continue to gain in importance in the coming years as the demand for safe and high-quality medical devices continues to grow worldwide.
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