Enforced since May 26, 2021, MDR replaces the older Directives 93/42/EEC (MDD) and 90/385/EEC on active implantable devices, introducing more stringent requirements across the entire life cycle of a device.
Adhering to MDR is more than just fulfilling regulatory demands—it's about improving the quality, safety, and reliability of your products, while positioning your devices to succeed in a fast-paced and competitive market. By embracing MDR, companies can ensure better patient outcomes, increase market trust, and lead the way in medical innovation.
The New Challenges Under MDR
MDR places far higher expectations on manufacturers than its predecessors. Key changes include:
- More rigorous conformity assessments: Notified Bodies now apply stricter evaluations of product equivalence and technical documentation.
- Stronger clinical data requirements: Clinical data and the Clinical Evaluation Report (CER) face intense scrutiny, requiring frequent updates and comprehensive evidence of safety and efficacy.
- Expanded post-market surveillance: Manufacturers are now obligated to conduct more Post-Market Clinical Follow-up (PMCF) studies and submit Periodic Safety Update Reports (for Class IIa devices and higher).
For many companies, this shift might seem overwhelming. The transition to MDR demands significant resources—both financial and operational—alongside a deep commitment to enhancing technical expertise. But with the right guidance and support, the MDR process can be managed effectively and lead to long-term benefits for your business.
Your First Steps to MDR Compliance
- Compliance Assessment: Begin with a comprehensive gap analysis to assess your current status and create a task list for updating procedures, technical files, and documentation.
- Marketing Claims: Ensure that all claims made about your device are backed by up-to-date clinical data and are defensible under the new standards.
- Portfolio Review: Decide which products in your portfolio should transition under MDR and where your investments will have the most impact.
- Notified Body Coordination: Check if your current Notified Body can handle your MDR certification needs and ensure that your timeline aligns with their capacity.
- Classification Changes: Review whether any classification changes affect your devices and adjust your conformity assessment routes accordingly.
- Technical Documentation Readiness: Ensure that full technical documentation, including updated post-market clinical data, is available for every device you market.
- IT Systems Preparedness: Invest in upgrading IT systems to support the new requirements, particularly around Unique Device Identification (UDI) and EUDAMED database readiness.
Why QACS Is Your Ideal Partner
At QACS, The Challenge Test Laboratory, we provide a comprehensive solution to meet your testing and regulatory needs under MDR. Our GLP-certified and ISO 17025-accredited contract laboratory is uniquely equipped to offer a full spectrum of services, ensuring your medical devices meet the highest regulatory standards.
When it comes to regulatory compliance, QACS offers extensive support with navigating through the MDR transition. We assist companies in preparing their technical documentation for submission to Notified Bodies, ensuring that all aspects of your device are thoroughly addressed. Our regulatory consultants will guide you through the necessary steps, including testing, documentation, and certification, steps that will enable you to obtain the CE mark and market approval.
Additionally, our lab services extend beyond regulatory compliance. At QACS, we also offer additional testing services that ensure your products are not only safe but also meet efficacy claims, reinforcing your brand’s credibility in a competitive market. Our end-to-end services cover everything from chemical analysis, stability testing, and packaging evaluation to biocompatibility assessments and clinical efficacy studies. These services are designed to ensure that your devices not only comply with the latest regulations but also stand out in terms of quality and innovation.
Our experience and expertise allow us to anticipate the challenges manufacturers face during the transition to MDR. By partnering with QACS, you gain access to tailored consulting, state-of-the-art testing facilities, and the latest in regulatory knowledge—all designed to support your business from concept to commercialization.
QACS Lab further supports your Medical Device Testing needs with analytical testing & regulatory services.
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