EU MDR: Definition, Timelines, Requirements, and Compliance

Published: May 14, 2025

The European Union Medical Device Regulation (EU MDR), officially Regulation (EU) 2017/745, governs the production, distribution, marketing, and oversight of medical devices in the EU. The primary objective of the EU MDR is to enhance the safety, clinical performance, and quality of medical devices.

The EU MDR entered into force on May 25, 2017, with full application starting on May 26, 2021. A staggered transition period was introduced for legacy devices previously certified under MDD/AIMDD to avoid market disruption of medical devices. The EU MDR transitional timelines extend from 2026 to 2028, depending on device classification. For instance, Class III custom-made devices must comply by May 2026 and Class IIa /IIb (excluding implantables) by December 2028.

The EU MDR introduced several significant updates over the previous MDD including the inclusion of specific aesthetic devices and formally regulating Software as a Medical Device (SaMD). Key updates include a stricter clinical evaluation with ongoing Post-Market Clinical Follow-up (PMCF). Other updates include enhanced traceability via the Unique Device Identification (UDI) system and the EUDAMED system. Additionally, EU MDR mandates the role of the Person Responsible for Regulatory Compliance (PRRC), requires more robust technical documentation, and strengthens Notified Body oversight.

To comply with EU MDR, manufacturers must define their devices’ intended use and classification, establish a QMS aligned with the MDR, appoint a PRRC, and compile risk management files, CERs, and technical documentation. Economic operators must be registered in EUDAMED, and CE marking must be obtained through conformity assessments. Post-market requirements include vigilance reporting, PMS, and periodic updates.

Electronic Quality Management Systems (eQMS) helps ensure EU MDR compliance in medical device economic operators. SimplerQMS provides an eQMS that streamlines quality management processes and helps ensure regulatory compliance.

SimplerQMS offers comprehensive QMS modules covering document control, training, CAPA, audits, risk, and change management enabling medical device companies to maintain audit-ready aligned with EU MDR and ISO 13485 requirements.

Book a demo with our Quality Solutions Consultant today to discover how SimplerQMS can elevate your quality processes and help ensure EU MDR compliance.

What Is EU MDR?

The European Union Medical Device Regulation (EU MDR), formally known as Regulation (EU) 2017/745 or EU MDR 2017/745, governs all medical devices within the EU. Compared to the Medical Device Directive (MDD), the EU MDR introduces stricter requirements for risk management, technical documentation, clinical evaluation, post-market surveillance (PMS), and transparency.

Originally adopted in 2017 and effective from 26 May 2021, the EU MDR replaces two earlier directives: the Medical Device Directive (MDD, 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC). A staggered transition for EU MDR implementation was introduced until 2026–2028, depending on the device classification, to accommodate medical devices already on the market.

The primary purpose of the EU MDR is to ensure that medical devices (e.g., diagnostics, software, consumables, and implants) marketed in the EU are safe, effective, and manufactured under high-quality systems. Compliance with the EU MDR is mandatory for market access in the EU.

The EU MDR introduces a comprehensive framework regulating the full lifecycle of medical devices, from classification rules to conformity assessments and the responsibilities of economic operators.

What Is the Applicability of the EU MDR?

A medical device is any instrument, apparatus, implant, software, or similar article intended by the manufacturer for medical purposes such as diagnosis, monitoring, and treatment.

The EU MDR formally applies to the EU and is enforced in European Economic Area (EEA) countries under the EEA Agreement, namely Iceland, Liechtenstein, and Norway.

The 27 countries of the European Union are listed below.

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden

Medical device manufacturers based outside the EU or EEA must comply with EU MDR requirements to place medical devices within EU markets or territories. Such manufacturers must appoint an Authorized Representative (AR) established within the EU/EEA to act on their behalf.

Furthermore, the EU MDR defines strict obligations for economic operators involved in the medical device lifecycle, including manufacturers, Authorized Representatives, importers, and distributors. Manufacturers manage design, production, clinical evaluation, and compliance. Importers verify conformity before market placement. Distributors check labeling accuracy and the presence of required documentation. Each operator ensures traceability, incident reporting, and post-market surveillance (PMS) as specified by the regulation.

EU MDR excludes in vitro diagnostic devices (which are covered under EU IVDR), medicinal products, non-Annex XVI cosmetics, food, human tissue transplants, and wellness products without medical intent. These exclusions limit the regulation to products aligned with a medical purpose or those with comparable risk profiles.

What Is the Importance of EU MDR?

EU MDR ensures safe, effective, and high-quality medical devices across the EEA/EU. The regulation responds to past safety failures by strengthening clinical evaluation, risk management, PMS, and incident reporting. Manufacturers must continuously demonstrate long-term safety and performance through ongoing data analysis and monitoring.

The regulation harmonizes medical device laws across all EEA countries, removing inconsistencies from earlier directives and reinforcing legal clarity. This harmonization builds trust among healthcare professionals and patients. The EU MDR raises regulatory expectations globally and compels manufacturers to adopt higher documentation and quality requirements.

Additionally, compliance with the EU MDR accelerates access to international markets that model their frameworks after the EU MDR. Compliance with the EU MDR often serves as a benchmark for other markets, enabling faster entry into non-EU jurisdictions that recognize or adopt these requirements.

What Is the EU MDR Implementation Timeline and Transitional Provisions?

The implementation timeline and transitional provisions of the EU MDRhave evolved through amendments to accommodate practical challenges. The regulation entered into force on 25 May 2017, with full application starting on 26 May 2021, replacing the Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD).

The EU MDR implementation timeline is listed below.

Original Transition Period: 3 years (2017–2020).
Revised Date of Application: Delayed to 26 May 2021 via Regulation 2020/561.
Further Extensions: Introduced by Regulation (EU) 2023/607, creating staggered deadlines up to 31 December 2028.

The extended transition periods for existing medical devices to achieve EU MDR compliance are listed below.

Class III Custom-Made Implantable Devices: Deadline May 26, 2026
Class III and Class IIb Implantable Devices: Deadline December 31, 2027
Class IIb (Excluding Implantables), IIa, and Class I Sterile/Measuring Devices: Deadline December 31, 2028

Under the EU MDR, legacy devices refer to those previously CE-marked under the Medical Device Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) and placed on the market before the full application of EU MDR on 26 May 2021. These devices may continue to be marketed under their existing certificates, provided they remain compliant, pose no safety risks, and have not undergone significant changes in design or intended use. Class I devices under the MDD that require a Notified Body under the MDR (e.g., reusable surgical instruments or certain software) are also considered legacy devices if they were placed on the market before 26 May 2021.

Legacy devices may only qualify for extended certificate validity if specific conditions are met.

To benefit from the extended transition, manufacturers must comply with the requirements listed below.

Have a valid MDD/AIMDD certificate issued before 26 May 2021.
Apply to an MDR-designated Notified Body by 26 May 2024.
Sign a written agreement with a Notified Body by 26 September 2024.
Implement an MDR-compliant QMS by 26 May 2024.

Failure to meet the listed conditions disqualifies the medical device from extended validity.

The extended timeline aims to avoid device shortages while ensuring a progressive shift toward MDR-compliant systems that enhance device safety, transparency, and regulatory accountability.

Despite extended transition timelines under the EU MDR, implementation faces significant operational challenges due to limited Notified Body capacity and stricter technical documentation requirements.

These demands are challenging for small and medium-sized enterprises (SMEs), which often lack the resources to upgrade QMS, complete clinical evaluations, and submit compliant documentation on schedule. As a result, delays in certification processes pose a real risk of market disruption, potentially forcing the withdrawal of essential medical devices from the EU market.

What Is the EU MDR Medical Device Classification System?

EU MDR classifies devices into four categories namely Class I, IIa, IIb, and III based on risk, invasiveness, duration of use, and intended medical purpose. This EU MDR medical device classification system, governed by Annex VIII, determines the level of regulatory scrutiny and conformity assessment required for CE marking.

CE marking indicates that the product meets EU MDR or EU IVDR requirements, has passed the appropriate conformity assessment, and is authorized for free marketing and use throughout the EEA.

The EU MDR medical device classification system is listed below.

Class I: Class I encompasses low-risk non-invasive products like bandages and stethoscopes, with subcategories for sterile (Is) and measuring (Im) devices, and reusable surgical instruments (Ir).
Class IIa: Class IIa includes low to medium-risk devices typically intended for short-term use, such as dental fillings and hearing aids. Class IIa devices require a Notified Body review.
Class IIb: Class IIb covers medium- to high-risk devices often used for long-term treatment, and may include implantable or externally connected systems like infusion pumps and ventilators. Class IIb devices demand more rigorous technical assessments by Notified Body.
Class III: Class III devices are high-risk or critical devices such as pacemakers and implants, which require the strictest scrutiny through comprehensive conformity assessments, clinical evaluation, and ongoing PMS.

EU MDR formally includes Software as a Medical Device (SaMD), which is classified based on its role in diagnosis, therapy, or clinical decision-making. Software processing patient data or influencing treatment decisions often qualifies as Class IIa or higher. This reflects a major evolution from the previous MDD regime, which excluded many digital products.

What Is the EU MDR Regulation Structure?

EU MDR is a comprehensive legal regulation framework totaling 175 pages. EU MDR comprises 10 chapters, 123 articles, and 17 annexes.

The chapters cover all essential aspects of medical device regulation, including general provisions, classification rules, economic operator obligations, conformity assessment, clinical evaluation, PMS, vigilance reporting, and enforcement.

The EU MDR chapters are summarized in the table below.

Chapter	Title	Focus
I	Scope and Definitions	Defines medical devices, scope, and regulatory status.
II	Making Available on the Market and Putting Into Service of Devices, Obligations of Economic Operators, Reprocessing, CE Marking, Free Movement	Requirements for placing devices on the market and economic operators’ obligations.
III	Identification and Traceability of Devices, Registration of Devices and of Economic Operators, Summary of Safety and Clinical Performance, European Database on Medical Devices	UDI (Unique Device Identification) system, device registration, EUDAMED database.
IV	Notified Bodies	Requirements and designation process for notified bodies.
V	Classification and Conformity Assessment	Device classification rules and conformity assessment procedures.
VI	Clinical Evaluation and Investigations	Requirements for clinical evaluation, clinical investigation, and PMCF (Post-Market Clinical Follow-up).
VII	Post-Market Surveillance, Vigilance, and Market Surveillance	Manufacturer obligations for PMS, vigilance, incident reporting, FSCA, and market surveillance.
VIII	Cooperation Between Member States, Medical Device Coordination Group, Expert Laboratories, Expert Panels and Device Registers	Roles of Medical Device Coordination Group (MDCG), expert panels, and EU-level coordination.
IX	Confidentiality, Data Protection, Funding, and Penalties	Data protection, funding of regulatory activities, and enforcement measures.
X	Final Provisions	Transitional measures, repeal of MDD/AIMDD, and entry into force.

The articles outline specific legal responsibilities, CE marking protocols, device registration, Notified Body designation, and transitional requirements.

The annexes supplement the contents with classification rules, technical specifications, safety and performance criteria, conformity assessment procedures, and requirements for documentation.

The 17 EU MDR Annexes are summarized in the table below.

Annex	Title
I	General Safety and Performance Requirements (GSPR)
II	Technical Documentation
III	Technical Documentation on Post-Market Surveillance
IV	EU Declaration of Conformity
V	CE Marking of Conformity
VI	Information to be Submitted Upon the Registration of Devices and Economic Operators in Accordance with Articles 29(4) And 31, Core Data Elements to be Provided to the UDI Database Together with the UDI-DI in Accordance with Articles 28 And 29, and the UDI System
VII	Requirements to be met by Notified Bodies
VIII	Classification Rules
IX	Conformity Assessment Based on Quality Management System and on Assessment of Technical Documentation
X	Conformity Assessment Based on Type-Examination
XI	Conformity Assessment Based on Product Conformity Verification
XII	Certificates Issued by Notified Bodies
XIII	Procedure for Custom-Made Devices
XIV	Clinical Evaluation and Post-Market Clinical Follow-up
XV	Clinical Investigation
XVI	List of Groups of Products Without an Intended Medical Purpose Referred to in Article 1(2)
XVII	Correlation Table

This structured format allows EU MDR to address high-level regulatory principles and granular technical expectations, ensuring clarity and consistency for manufacturers, regulators, and other economic operators.

What Are the Key Changes Introduced by EU MDR Compared to EU MDD?

The key changes introduced by EU MDR compared to EU MDD are listed below.

Expanded Scope: EU MDR expands the scope to include Annex XVI products such as cosmetic implants, dermal fillers, and aesthetic non-medical devices with risk profiles comparable to medical devices. AIMD (Active Implantable Medical Devices) are now also covered under EU MDR.
Revised Medical Device Classification Rules: The EU MDR classification system imposes stricter rules on SaMD, implantable, and reusable surgical instruments. The classification rules lead to many medical devices being reclassified into higher-risk categories with stricter conformity assessment procedures.
Stricter Clinical Evaluation Requirements: Clinical evidence under EU MDR must be continuously updated through a Clinical Evaluation Report (CER) and Post-Market Clinical Follow-up (PMCF) activities, ensuring ongoing safety and performance evaluation.
Unique Device Identification (UDI): The mandatory UDI system improves device traceability through UDI labels on products and enables lifecycle tracking via the EUDAMED registration database.
Introduction of EUDAMED Database: EUDAMED is the centralized platform for device registration, vigilance reporting, and public access to Summary of Safety and Clinical Performance (SSCP) data for high-risk medical devices. The platform promotes transparency and strengthens regulatory oversight.
Greater Scrutiny of Notified Bodies: Notified Body requirements are now stricter, with re-designation procedures and enhanced auditing to ensure a unified, high-standard evaluation of devices across the EU.
Mandatory Person Responsible for Regulatory Compliance (PRRC): EU MDR requires all manufacturers and authorized representatives to appoint a qualified Person Responsible for Regulatory Compliance. The PRRC ensures technical documentation, vigilance reports, and clinical data comply with regulation requirements.
More Detailed Technical Documentation: EU MDR mandates expanded technical documentation, including details on risk management, device design, safety and performance, clinical evidence, labeling requirements, and manufacturing controls.
Post-Market Surveillance (PMS) System: Manufacturers must implement a PMS plan that incorporates vigilance reporting timelines, user feedback, and trend analysis, which feed into continuous compliance monitoring.
Transparency and Public Access: Certain device data and safety reports, including summaries of safety and clinical performance (SSCP) for Class III and implantable devices, must be made accessible to the public.

What Are the Main Challenges of Transitioning to EU MDR?

Several main challenges of economic operators transitioning to the EU MDR are listed below.

Notified Body Capacity Constraints: EU MDR faces a Notified Body bottleneck due to the limited number of designated Conformity Assessment Bodies. This shortage results in long certification workflows, application backlogs, and delayed market access for manufacturers.
Increased Documentation Requirements: The EU MDR demands significantly more robust risk management documentation, detailed clinical data, and structured design dossiers. These requirements place significant pressure on internal teams and resource capacity.
Stricter Clinical Evidence Requirements: Recertification requires a new CER and an evidence-based PMCF plan for many legacy medical devices. The expectations for proving safety and performance for medical devices are much higher, even for well-established products.
Complexity in Medical Device Reclassification: Under the MDR, many devices, especially those previously in Class I, have moved to higher-risk classifications. This shift triggers additional conformity assessment procedures, documentation updates, and a Notified Body review.
Implementation of Unique Device Identification (UDI): EU MDR requires UDI systems to integrate into labeling software, data repositories, and the EUDAMED database. Each UDI system must include both the UDI-DI (device identifier) and UDI-PI (production identifier) components.
Establishing Post-Market Surveillance Systems: New requirements like periodic safety update reports (PSURs) and active PMCF tracking raise the bar for post-market clinical evaluation. PMS system increases both the data workload and regulatory oversight.
Resource and Cost Pressures: Small and medium-sized manufacturers (SMEs) face steep compliance costs, which require additional headcount, consultation fees, and system overhauls. These challenges affect their business models and timelines.
IT System Readiness for EUDAMED: Uncertainty about EUDAMED module availability complicates UDI uploads and ongoing device registration, reducing overall regulatory readiness.
Training and Competence Gaps: EU MDR requires internal staff to complete training programs covering QMS updates, CER methodologies, and audit readiness checklists. This training ensures staff can meet the regulations’ expectations.

How to Ensure EU MDR Compliance?

EU MDR compliance means meeting all requirements under Regulation (EU) 2017/745 to ensure medical device safety, clinical performance, traceability, and post-market oversight. Compliance is mandatory for obtaining and maintaining CE marking, which allows legal market access in the EU.

The steps to ensure EU MDR compliance for manufacturers, according to eumdr.com, are listed below.

Decide the Intended Use and Classification: Define the device’s intended purpose under EU MDR and determine its class (Class I, IIa, IIb, or III) using official Device Classification Rules. This foundational step impacts the entire conformity assessment procedure.
Establish the Necessary Processes and Resources: Establish a Quality Management System (QMS) and consider referencing ISO 13485, ensuring adequate medical and regulatory oversight. Appoint a PRRC who meets the EU MDR’s strict qualification criteria.
Minimize Risks and Fulfil the General Safety and Performance Requirements (GSPRs): Develop a risk management file and ensure your medical device design complies with GSPRs from Annex I. Use a GSPR checklist for structured evaluation.
Complete the Clinical Evaluation: Generate or reference clinical data through studies or clinical equivalence. Compile it in a Clinical Evaluation Report (CER) and, prepare a PMCF plan, as applicable, as part of your clinical evidence strategy.
Complete the Technical Documentation: Gather the technical file covering device description, design verification, validation, UDI-DI and UDI-PI identifiers, and labeling. Include safety and performance testing aligned with requirements.
Make Arrangements for Distribution: Identify authorized representatives, importers, and distributors as applicable. Define their roles and compliance responsibilities under Articles 11–14, ensuring complete transparency throughout the supply chain.
Register the Device and the Manufacturer: Assign a Basic UDI-DI to the device, submit relevant data through EUDAMED module submissions, and obtain a Single Registration Number (SRN) for both the manufacturer and Authorized Representative.
Complete the Conformity Assessment: For Class Is, Im, Ir devices or higher, engage a Notified Body for QMS audit and documentation review. Follow the formal CE marking process to secure regulatory approval.
Complete the Final Administrative Procedures: Draft the EU Declaration of Conformity, correctly affix the CE marking, and prepare Instructions for Use (IFU) and multilingual labeling in accordance with MDR Annex I.
Fulfill the Obligations in the Post-Market Phase: Implement a PMS system, submit PSURs, update PMCF documentation, and submit vigilance reports in line with MDR reporting deadlines.

The authorized representative (AR) should consider the following elements below to ensure EU MDR compliance.

Establish a Written Mandate: Under MDR Article 11, the non-EU manufacturer and the AR must sign a written mandate agreement. This document outlines specific regulatory representation responsibilities and must be retained for compliance audits. The AR must be physically located within the EU and formally empowered to act on behalf of the manufacturer.
Verify Manufacturer Compliance: Before placing a device on the EU market, the AR must confirm that the EU Declaration of Conformity has been drawn up and that the correct conformity assessment procedure has been completed, including CE certification, if applicable.
Maintain Technical Documentation Access: EU MDR Article 11(3) requires the Authorized Representative to maintain continuous access to technical documentation, certificates, and Declarations of Conformity, including all updates and supplements. The AR must present these documents to competent authorities upon request.
Ensure Device Registration in EUDAMED: EU MDR requires the Authorized Representative to verify that the Basic UDI-DI and device-specific data are entered correctly in EUDAMED. The AR must also ensure the manufacturer’s SRN is valid and linked to the AR in the system.
Cooperate with Authorities: The AR acts as the first point of contact for vigilance reporting, corrective actions, and other regulatory requests. Prompt communication with both competent authorities and the manufacturer is essential to maintaining regulatory compliance.
Monitor Compliance and Report Issues: AR must actively monitor product complaints, serious incidents, or signs of non-conformity. If the manufacturer fails to take corrective action, the AR is obligated to terminate the mandate and inform the relevant Member State authority and Notified Body, as per Article 11(3)(h).
Avoid Delegation of Manufacturer Responsibilities: Per MDR Article 11 (4), the AR cannot assume tasks reserved solely for the manufacturer, such as device design, QMS development, or authoring technical documentation.
Access to Regulatory Compliance Expertise: The AR must maintain access to a PRRC under Article 15(6). The PRRC may be outsourced or employed internally but must be qualified and continuously available.
Handle Mandate Transitions Correctly: EU MDR Article 12 requires the manufacturer, outgoing Authorized Representative (AR), and incoming AR to coordinate the transfer of documentation and responsibilities. This coordination ensures a clear transition protocol.
Understand AR Liability: The AR shares regulatory liability with the manufacturer for non-compliance, including potential joint responsibility for defective products under Article 11(5).

The recommended steps for importers to ensure EU MDR compliance are listed below.

Verify CE Marking and Documentation: EU MDR requires each device placed on the EU market to bear a valid CE mark, be appropriately labeled according to MDR (including Instructions for Use in appropriate EU languages), and be accompanied by an up-to-date EU Declaration of Conformity (DoC). A formal CE mark verification protocol must be established for every shipment. The importer must maintain a copy of the DoC per record retention requirements.
Check Device Registration in EUDAMED: Confirm that the manufacturer and device are properly listed in the EUDAMED database, including verification of the UDI-DI and UDI-PI. Regular checks must be performed against SRN and the manufacturer’s EUDAMED entries.
Label Importer Information Clearly: As required by MDR Article 13(3), clearly mark the importer’s name, registered business address, and contact details on the device label, packaging, or accompanying documents to ensure traceability and accountability.
Assess Product Compliance Before Market Placement: If a device appears non-conforming, falsified, or lacks mandatory documentation, the importer must refrain from market release. Initiate a formal non-compliance alert protocol, and inform the manufacturer, Authorized Representative, and competent authority as necessary.
Ensure Proper Storage and Transport Conditions: To preserve medical device integrity and compliance, maintain and monitor storage and transport conditions to ensure alignment with manufacturer specifications. This includes validating environmental controls (e.g., temperature, humidity) and implementing defined product handling procedures.
Maintain a Complaint and Recall Register: Keep comprehensive records of customer complaints, recalls, withdrawals, and non-compliant products. Share updates with the manufacturer and Authorized Representative, supporting a coordinated corrective action plan.
Report Serious Risks or Falsification: The importer must report immediately to the competent authority and assist in any resulting health risk investigations if the product presents a serious health risk or is suspected to be counterfeit.
Cooperate with Authorities and Provide Access: Provide device samples, documentation, or warehouse access for inspection, if requested. Consider developing a sampling request-response protocol to handle national authority inquiries efficiently and transparently.

A medical device distributor can consider the following steps below to ensure EU MDR compliance.

Verify CE Marking and Labelling: Ensure that every medical device is affixed with a valid CE marking, up-to-date EU Declaration of Conformity is available, and that the labeling and Instructions for Use (IFU) are in the official language(s) of the Member State where it is distributed. Utilize a CE mark verification checklist to standardize compliance review.
Confirm Importer Information and UDI: Check that the importer’s name and address are clearly indicated on the product, packaging, or accompanying documentation. Confirm that the UDI-DI and UDI-PI identifiers are affixed and formatted correctly according to MDR traceability requirements.
Use Representative Sampling for Checks: Conduct representative batch sampling to verify that product packaging, documentation, and CE markings remain consistent with compliance requirements.
Ensure Proper Storage and Transport Conditions: Maintain and monitor storage environments in line with manufacturer specifications. Use temperature and humidity log sheets or automated tracking systems to document storage and transportation conditions that impact medical device conformity.
Withhold Non-Compliant Devices from Market: Do not distribute if a device is found to be falsified, nonconforming, or poses a serious health risk. Inform the manufacturer, importer, or AR immediately. Consider initiating a regulatory escalation workflow to standardize the process.
Report Suspected Safety or Compliance Issues: Upon identifying a potentially dangerous or non-compliant product, promptly notify the competent authority and cooperate fully with their requests. Consider having a falsified/nonconforming product reporting template readily accessible for standardized communication.
Maintain a Complaint and Incident Register: Record and track all product complaints, recalls, nonconformities, and withdrawals using a centralized incident tracking system. Share this data with the manufacturer and other relevant economic operators for prompt action.
Cooperate with Regulatory Authorities: Provide immediate access to traceability records, UDI data, and distribution documentation in response to regulatory inspections or documentation requests.

How Does the EU MDR Differ From ISO 13485?

The main differences between EU MDR and ISO 13485 are in terms of legal status, scope, geographical applicability, compliance objective, and Notified Body involvement.

The EU MDR is a legally binding regulation required for medical device market access in the EU. In contrast, ISO 13485 is a voluntary international quality management standard.

The EU MDR scope governs the full lifecycle and legal placement of medical devices, while ISO 13485 governs medical device quality management systems.

EU MDR applies only within the EU and EEA. ISO 13485 is globally recognized and adopted in jurisdictions such as Canada, Australia, and Japan.

For compliance objectives, the EU MDR ensures medical devices’ safety, performance, and legal compliance, acting as a gateway for access to the EU market. In contrast, ISO 13485 provides a globally recognized QMS framework that helps manufacturers meet regulatory and customer requirements, though it does not alone grant legal market access in the EU.

Moreover, EU MDR requires a formal conformity assessment process conducted by a Notified Body for most medical devices, which is a prerequisite for obtaining CE marking and legal market placement within the EU. Conversely, ISO 13485 certification is granted by accredited third-party bodies. The ISO 13485 certification is evidence of a robust QMS.

How Does the EU MDR Differ From EU IVDR?

The main difference between EU MDR and EU IVDR (Regulation (EU) 2017/746) is the type of products they regulate, classification rules, conformity assessment, clinical requirements, and transition periods.

The EU MDR governs medical devices, while the EU IVDR regulates in vitro diagnostic medical devices (IVDs) used to examine specimens from the human body. IVDs include COVID-19 test kits, pregnancy tests, and genetic tests.

EU MDR classifies medical devices into four categories: Class I, IIa, IIb, and III. EU IVDR introduces a new risk-based system with Classes A, B, C, and D, where Class D represents the highest risk (e.g., devices used in blood screening for infectious agents).

For conformity assessment, Class I devices are self-certified, while higher classes require involvement from the Notified Body. EU IVDR, on the other hand, only Class A non-sterile devices remain self-certified.

EU MDR places significant emphasis on clinical evaluation, clinical investigations, and PMCF, reflecting its lifecycle-based regulatory approach. EU IVDR focuses on performance evaluation, integrating scientific validity, analytical performance, and clinical performance to ensure ongoing reliability and safety of the IVD.

The EU MDR has been fully applicable since May 26, 2021, and precedes the EU IVDR, which became applicable on May 26, 2022.

What Is the Role of QMS Software in Ensuring EU MDR Compliance?

An electronic Quality Management System (eQMS) is a cloud-based, software-driven solution that empowers medical device economic operators to digitize, automate, and streamline their quality and compliance workflows.

An electronic QMS is instrumental in achieving compliance, offering a structured, traceable, and auditable digital framework that automates and centralizes quality operations.

The areas where medical device QMS software facilitates compliance with the EU MDR are listed below.

Centralized Document Management and Control: A robust eQMS ensures secure and centralized document management. It provides real-time version control, electronic signatures, and automated access permissions.
Automated Workflows for QMS Processes: Built-in automation for processes such as CAPA, internal audits, and change management, among others, ensures traceability, workflow standardization, and compliance with Article 10 of EU MDR.
Integrated Risk Management and Clinical Evaluation Tracking: eQMS solutions integrate risk management, clinical evaluation, and technical documentation within a unified digital framework to seamlessly align with relevant guidance documents.
Monitoring of PMS and Vigilance Reporting: eQMS facilitates PMS, PMCF, and vigilance reporting through reports, automated scheduling, and dashboards, enabling timely submission and proactive compliance monitoring.
UDI and Traceability Record-Keeping: eQMS stores and links UDI-DI and UDI-PI with device history records and batch releases, facilitating end-to-end traceability across the product lifecycle.

By digitizing quality processes, medical device companies can significantly enhance their ability to comply with the EU MDR. eQMS streamlines operations, reduces manual errors, and improves overall efficiency, making organizations more agile and responsive to regulatory demands. Furthermore, a cloud-based infrastructure supports scalability and facilitates global compliance, aligning organizational quality systems with EU MDR and other international regulatory frameworks.

SimplerQMS provides a GAMP5-validated, cloud-based eQMS tailored for the medical device industry. Designed to meet EU MDR and ISO 13485, SimplerQMS integrates core quality functions into a unified platform while being compliant with FDA 21 CFR Part 11 and EU GMP Annex 11.

SimplerQMS has automated modules that include document control, training management, CAPA management, change management, risk assessment, supplier oversight, audit management, and more.

Book a demo with our Quality Solutions Consultant to see how SimplerQMS can support your compliance with EU MDR.