FAQ
Comprehensive MDR & IVDR FAQ covering medical device compliance, technical documentation, ISO 13485 QMS, clinical evaluation, risk management, and post-market s...
MDR & IVDR
Basics
1What Is EU MDR And Why Is It Important For Medical Device Manufacturers?
EU MDR (Medical Device Regulation 2017/745) is the European Union's mandatory regulatory framework for medical devices. Since May 26, 2021, all medical devices sold in the EU must comply with MDR requirements. It significantly increases documentation requirements, clinical evidence standards, and post-market surveillance obligations compared to the previous MDD directive. Non-compliance can result in market access denial, product recalls, and significant financial penalties.
2What Is The Difference Between MDR And IVDR?
MDR (Medical Device Regulation) applies to medical devices, while IVDR (In Vitro Diagnostic Regulation 2017/746) specifically governs in vitro diagnostic devices. IVDR has a risk-based classification system with 4 classes (A, B, C, D) and requires more extensive clinical evidence. Both regulations share similar structural requirements but have different technical documentation specifics. IVDR implementation began in 2022 with staggered transition dates based on device risk classification.
3How Long Does The MDR Certification Process Take?
MDR certification timelines vary significantly based on device class, complexity, and current compliance status. Class I devices typically take 3-6 months, Class IIa/IIb devices 6-12 months, and Class III devices 12-24 months. Factors affecting timeline include technical documentation completeness, clinical evaluation requirements, notified body availability, and gap analysis findings. Early engagement with a qualified consultant can significantly accelerate the process.
4What Is A Technical File And What Does It Include?
A technical file is a comprehensive documentation package required for MDR compliance. It must include device description and specifications, design and manufacturing information, general safety and performance requirements, benefit-risk analysis and risk management documentation, clinical evaluation reports, post-market surveillance plan, and labeling information. Annex II and III of MDR provide detailed requirements for technical documentation structure and content.
ISO Standards
& QMS
1What Is ISO 13485 And Why Is It Required For MDR Compliance?
ISO 13485:2016 is the internationally recognized standard for Quality Management Systems specifically designed for medical device manufacturers. While not legally mandatory, MDR Article 10 requires manufacturers to have a quality management system that ensures compliance with essential safety requirements. ISO 13485 provides the framework that satisfies this requirement and is typically a prerequisite for notified body certification. The standard covers design development, production, storage, installation, and servicing of medical devices.
2How Does ISO 14971 Relate To MDR Risk Management Requirements?
ISO 14971 is the international standard for application of risk management to medical devices. MDR explicitly requires a comprehensive risk management process as part of technical documentation. This includes risk analysis, risk evaluation, risk control, and residual risk assessment throughout the product lifecycle. ISO 14971:2019 version is the current standard and must be applied systematically. Our consultants help manufacturers establish compliant risk management files that satisfy both ISO 14971 and MDR requirements.
3What Are The Key Differences Between ISO 13485 And FDA 21 CFR 820?
While both standards address QMS for medical devices, there are significant differences. ISO 13485 is internationally recognized and required for CE marking under MDR, while FDA 21 CFR 820 applies only to devices marketed in the United States. FDA requirements are more prescriptive in certain areas, while ISO 13485 allows more flexibility in implementation. Many manufacturers seek compliance with both standards to access global markets. Our consultants can help align your QMS to meet both regulatory frameworks simultaneously.
4What Documentation Is Required For ISO 13485 Implementation?
ISO 13485 requires a documented QMS including quality manual, quality policy and objectives, control of documents and records, management responsibility, resource management, product realization processes, measurement analysis and improvement procedures. Key documents include design control procedures, purchasing controls, production and service controls, corrective and preventive action procedures, and internal audit records. The extent of documentation depends on company size and device complexity.
Clinical
Evaluation
1What Is A Clinical Evaluation Report And When Is It Required?
A Clinical Evaluation Report (CER) is a systematic documentation process demonstrating that a medical device meets safety and performance requirements. Required under MDR Article 61, it must include clinical data from literature review, clinical experience, and clinical investigations. The CER is a critical component of technical documentation and must be continuously updated throughout the device lifecycle. Our expert team assists in preparing comprehensive CERs that satisfy notified body scrutiny.
2What Is The Difference Between Literature Review And Clinical Investigations?
Literature review uses existing clinical data from published studies and post-market experience with equivalent devices. Clinical investigations involve prospective data collection through clinical trials on your specific device. Lower risk devices may rely primarily on literature, while Class III and high-risk Class IIb devices typically require clinical investigation data. MDR emphasizes equivalence demonstration more strictly, requiring substantial evidence of technical, biological, and clinical equivalence.
3What Is Post Market Clinical Follow-up And When Is It Required?
Post Market Clinical Follow-up (PMCF) is ongoing collection of clinical data after device placement on the market. Required under MDR Article 120 for Class IIa, IIb, and III devices, it supplements clinical evaluation with real-world evidence. PMCF activities may include registries, post-market surveys, and clinical investigations. Our consultants help develop compliant PMCF plans and reports that proactively address potential safety concerns.
4How Do I Establish Equivalence For Literature-Based Clinical Evaluation?
MDR Article 5 requires demonstration of equivalence with devices already on the EU market. You must prove technical equivalence (design, materials, specifications), biological equivalence (same body contact and duration), and clinical equivalence (same intended use and user profile). The technical file must include sufficient data to demonstrate equivalence without access to proprietary information. This is one of the most challenging MDR requirements where expert guidance is invaluable.
Post-Market
Requirements
1What Is Post Market Surveillance And What Are The Requirements?
Post Market Surveillance (PMS) is the systematic process of collecting and analyzing post-market data. MDR Article 83 mandates a PMS system proportionate to device risk. Class I devices require a basic PMS system, Class IIa/IIb require an active surveillance system, and Class III/implantable devices require a PMCF system. The PMS plan must include complaint handling, trend reporting, corrective actions, and periodic safety update reports (PSUR) for higher-risk devices.
2What Is A Periodic Safety Update Report And Which Devices Require It?
A Periodic Safety Update Report (PSUR) summarizes PMS data analysis and is required for Class IIa, IIb, and III devices annually, or every two years for Class IIa. PSURs must include benefit-risk conclusions, corrective actions taken, main findings from PMCF, and sales/distribution data. These reports must be submitted to the notified body for review and made available to competent authorities upon request.
3What Are The Vigilance Reporting Requirements Under MDR?
MDR Article 87 requires manufacturers to report serious incidents and field safety corrective actions to relevant authorities. Serious incidents must be reported within 2-15 days depending on severity. Field safety corrective actions (FSCAs) must be communicated to affected parties. The EUDAMED system will eventually be the platform for vigilance reporting. Our consultants help establish robust vigilance procedures and ensure timely compliance.
4How Do I Set Up An Effective PMS System For My Company?
An effective PMS system requires documented procedures for data collection (complaints, literature, clinical studies), data analysis methods, trending and reporting processes, and feedback mechanisms to design and production. The system should be integrated with your quality management system and risk management processes. Our experts help develop customized PMS plans that meet MDR requirements while being practical for your organization size and device portfolio.
Working
With Us
1Why Should I Choose MDRCert For My Regulatory Consulting Needs?
MDRCert brings unique expertise through our team's direct experience with notified body processes. Our consultants include former notified body professionals who understand exactly what auditors look for in technical documentation. We offer comprehensive services spanning MDR, IVDR, ISO 13485, and ISO 14971, providing a one-stop solution for medical device compliance. With 35+ clients and 125+ successfully completed projects, we have proven track record across all device classes.
2What Is The Process For Engaging MDRCert Services?
Our engagement process begins with a free initial consultation to understand your device, current compliance status, and timeline requirements. We then conduct a comprehensive gap analysis to identify areas requiring attention. Based on findings, we provide a detailed proposal with scope, timeline, and pricing. Upon engagement, our team works closely with yours to develop required documentation and implement necessary processes. We maintain transparent communication throughout and provide ongoing support as needed.
3What Types Of Medical Devices Do You Work With?
MDRCert has experience across all medical device classifications from Class I to Class III, as well as in vitro diagnostic devices under IVDR. Our expertise spans therapeutic devices, diagnostic equipment, surgical instruments, active implantable devices, software as medical device (SaMD), and combination products. We work with both established manufacturers and innovative startups entering the market for the first time.
4How Much Does MDR Consulting Services Cost?
Consulting costs vary based on device complexity, current compliance status, scope of services required, and timeline. We offer flexible engagement models including project-based pricing, hourly consulting, and retainer arrangements. During our initial consultation, we provide a detailed quote based on your specific requirements. We strive to deliver cost-effective solutions that maximize value while ensuring regulatory compliance.
5Where Is MDRCert Located And What Regions Do You Serve?
MDRCert is based in Podgorica, Montenegro, strategically positioned to serve clients across Europe and globally. Our location offers competitive consulting rates while maintaining full compliance with EU MDR requirements. We serve medical device manufacturers worldwide, with particular expertise in EU market access. Our team can work remotely with clients anywhere, and we have experience navigating multi-jurisdictional regulatory requirements.
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