What is MDR (EU) 2017/745?

MDR (EU) 2017/745 is the European Medical Device Regulation that establishes the regulatory framework for medical devices in the European Union, replacing the previous Medical Device Directive (MDD).

Who needs to comply with MDR?

All manufacturers placing medical devices on the EU market must comply with MDR, regardless of where they are based. This includes manufacturers, authorized representatives, importers, and distributors.

What are the key changes from MDD to MDR?

Key changes include stricter clinical evidence requirements, enhanced post-market surveillance obligations, new classification rules, mandatory unique device identification (UDI), and increased transparency through the EUDAMED database.

How does Udem Atlantic support MDR compliance?

As a Notified Body, Udem Atlantic provides conformity assessment services including technical documentation review, quality management system audits, and type examination for medical devices under MDR.

MDR (EU) 2017/745 Medical Device Regulation

MDR (EU) 2017/745 Medical Device Regulation Certification

The European Union Medical Device Regulation (EU) 2017/745 establishes a comprehensive regulatory framework for medical devices placed on the European market. Conformity assessment procedures under MDR are carried out by a notified body to ensure that medical devices comply with the applicable safety and performance requirements. UDEM Atlantic operates as the Official Contact Office for UDEM A.Ş., facilitating communication and coordination with manufacturers in relation to these regulatory processes.

What Is EU MDR 2017/745?

The Medical Device Regulation (EU) 2017/745, commonly referred to as EU MDR, is the principal legislation governing the placing of medical devices on the European Union market. It replaced the former Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC), bringing a significantly strengthened regulatory framework that prioritizes patient safety, device performance, and post-market surveillance.

EU MDR applies to a wide range of products, including diagnostic equipment, surgical instruments, implantable devices, software as a medical device (SaMD), and accessories. The regulation introduced more stringent requirements for clinical evidence, risk management, traceability through the Unique Device Identification (UDI) system, and transparency via the European Database on Medical Devices (EUDAMED).

Why MDR Matters for Manufacturers

For manufacturers — whether based in the EU, the United States, or elsewhere — compliance with MDR is mandatory for any medical device intended for the European market. The regulation imposes obligations throughout the entire product lifecycle, from design and manufacturing through post-market surveillance and vigilance reporting.

US manufacturers seeking to enter or maintain access to the EU market must work with a designated EU Notified Body to undergo conformity assessment. This process verifies that devices meet the general safety and performance requirements (GSPRs) set out in Annex I of the regulation, and that the manufacturer's quality management system is adequate for the devices in question.

Types of Devices Covered

Udem Atlantic provides conformity assessment services for a broad range of medical devices under MDR, including but not limited to:

Non-active implantable devices (orthopedic implants, cardiovascular stents, dental implants)
Active therapeutic and diagnostic devices
Reusable surgical instruments
Software as a Medical Device (SaMD), including clinical decision support and monitoring applications
Class IIa, IIb, and Class III medical devices
Custom-made devices and device accessories

Key Requirements of MDR

The MDR establishes comprehensive requirements that manufacturers must satisfy. Key areas include:

General Safety and Performance Requirements (GSPRs): Annex I of MDR defines the essential requirements that all devices must meet, covering risk management, design, manufacturing, and labeling.
Clinical Evaluation: Manufacturers must demonstrate sufficient clinical evidence to support the safety and performance of their device, following Article 61 and Annex XIV.
Technical Documentation: Comprehensive technical documentation must be compiled in accordance with Annexes II and III, covering the device description, design and manufacturing information, risk–benefit analysis, and clinical data.
Quality Management System: Manufacturers must implement and maintain a quality management system (typically aligned with ISO 13485) that covers all aspects of the device lifecycle.
Post-Market Surveillance (PMS): A proactive and systematic PMS plan must be established to continuously gather, analyze, and act on device performance data after market placement.
Unique Device Identification (UDI): All devices must carry a UDI to ensure traceability throughout the supply chain and facilitate vigilance activities.

Timeline and Expectations

The duration of the MDR conformity assessment process varies depending on the device risk class, the complexity of the technical documentation, and the readiness of the manufacturer's quality management system. Typical timelines range from several months for lower-risk devices to over a year for complex Class III devices or those requiring clinical investigations.

Udem Atlantic is committed to transparent communication throughout the process. We provide clear milestones, expected timelines, and regular status updates so manufacturers can plan their market access strategy with confidence.

To begin the certification process, request a quote or contact our team to discuss your specific requirements.