MDD to MDR – What Medical Device Manufactures need to know

What was the Medical Device Directive (MDD)?

The Medical Device Directive (93/42/EEC) was a European Union directive established in 1993 to regulate the safety and performance of medical devices marketed in the EU. It provided the legal framework for manufacturers to obtain CE marking, which allowed devices to be sold across EU member states. The directive required manufacturers to demonstrate that their products met essential requirements related to safety, quality, and efficacy. Compliance was assessed through conformity procedures involving Notified Bodies, especially higher-risk devices.

However, the MDD had limitations, including inconsistent implementation across countries, insufficient post-market surveillance, and outdated provisions that didn’t keep pace with technological advancements. These shortcomings led to the development of the Medical Device Regulation (MDR), which replaced the MDD, creating a more robust, harmonized, and transparent regulatory system.

Key differences between MDD and MDR: What has changed in the regulation?

Key technical changes include a broadened scope encompassing certain aesthetic devices and standalone software, a reclassification of devices based on a more stringent risk-based system, and enhanced requirements for clinical evaluation and post-market surveillance. The MDR mandates comprehensive technical documentation aligned with Annexes II and III, implementation of a robust Quality Management System (QMS) per Article 10, and designation of a Person Responsible for Regulatory Compliance (PRRC).

Additionally, the regulation enforces Unique Device Identification (UDI) for traceability and integrates device data into the EUDAMED database for transparency. Notified Bodies now operate under stricter designation criteria, reducing their number and increasing scrutiny during conformity assessments. Legacy devices certified under the MDD may continue to be marketed under extended transitional provisions, provided no significant changes are made, and MDR applications are submitted on time.

Manufacturers must ensure continuous compliance through lifecycle risk management, updated clinical evidence, and vigilance reporting, as non-compliance may result in market withdrawal. The MDR thus imposes a more rigorous, transparent, and safety-oriented regulatory environment, demanding strategic adaptation from all economic operators in the medical device sector.

The EU Medical Device Regulation (MDR) is the most significant update to European medical device law in decades, replacing the former Medical Device Directive (MDD). Unlike a directive, which requires translation into national law, the MDR is a regulation with binding legal force across all EU member states. This creates a harmonized, predictable, and robust regulatory framework. Its primary goal is to enhance patient safety through a comprehensive, lifecycle-based approach to device regulation, extending rigorous oversight from initial concept through to post-market surveillance.

EU MDR compliance is not just a regulatory hurdle; it is a commitment to the highest standards of patient safety and a prerequisite for market access. The regulation ensures that all medical devices undergo rigorous scrutiny to prove their safety and performance claims.

For manufacturers, achieving MDR certification is the key that unlocks the European market of over 450 million people. It demonstrates their dedication to quality and provides a competitive advantage, building trust with healthcare providers, partners, and patients alike.

The MDR introduces several critical changes and heightened requirements that manufacturers must address. Understanding these pillars is the first step toward successful certification.

Scope of the transition from MDD to MDR

The regulation now covers a broader range of products, including certain devices without a medical purpose (e.g., cosmetic implants, dermal fillers) and devices used for cleaning or sterilizing other medical devices.

Clinical requirements: New MDR requirements compared to MDD

The MDR demands more robust clinical evidence to substantiate safety and performance claims. The reliance on data from 'equivalent' devices is now severely restricted, often necessitating new clinical investigations and continuous data collection throughout the product lifecycle (PMCF).

Enhanced Traceability (UDI System)

The mandatory Unique Device Identification (UDI) system provides unambiguous traceability for every device throughout the supply chain, enhancing the effectiveness of post-market safety activities like recalls and vigilance reporting.

Increased Transparency (EUDAMED)

The European Database on Medical Devices (EUDAMED) is a publicly accessible hub for device information, including certificates, clinical investigations, and vigilance reports, leading to greater scrutiny from regulators and the public.

Total Lifecycle Approach

The regulatory focus has shifted from pre-market approval to a holistic view of the entire product lifecycle, mandating proactive Post-Market Surveillance (PMS) and continuous updates to technical documentation.

What is the difference with FDA regulations?

While both frameworks aim for high safety standards, the EU and US regulatory pathways have distinct structural differences. The US system is centralized under the FDA, which clears devices through established routes like the 510(k) or Premarket Approval (PMA) processes.

In contrast, the EU’s MDR employs a decentralized model, where manufacturers partner with a designated Notified Body. The MDR is also distinguished by its strong emphasis on a total lifecycle approach, mandating more rigorous clinical evidence, enhanced transparency through the EUDAMED database, and comprehensive traceability via the UDI system.

How to manage the transition from MDD to MDR: Certification process

We believe in a transparent, predictable, and collaborative certification journey. Our four-phase process is designed to provide clarity and support at every stage, enabling you to navigate the certification journey with confidence and thorough preparation.

• Phase 1: Structured Dialogue

Before applying, we organize a structured dialog with the applicant, to review feasibility, confirm scope, and clarify timelines, procedures, and documentation. We also define the most suitable conformity assessment route, typically Annex IX for QMS and Technical Documentation, or alternatives like Annex XI for production assurance.

• Phase 2: Application and Engagement

After agreement, a dedicated project leader will support you and and oversee your project throughout the entire process. We check your Technical Documentation for completeness to avoid delays before starting the detailed assessment.

• Phase 3: Assessment Activities​​​

Our experts perform a two-stage QMS site audit and an in-depth Technical Documentation review. The level of scrutiny depends on risk class, including clinical evaluation to validate safety and performance claims.

• Phase 4: Certification and CE Marking

​​​​​Once all the non-conformities have been addressed by the client, an independent panel makes the final decision. Upon approval, we issue MDR certificates, enabling you to declare conformity and affix the CE marking.

Conclusion: From MDD to MDR, a permanent commitment

While the primary transition deadlines have passed, continuous compliance is an ongoing journey. The MDR requires a permanent commitment to lifecycle management. Manufacturers with legacy devices still on the market under valid MDD certificates must be vigilant; any 'significant change' to the device's design or intended purpose will trigger the need for full MDR certification.
Our post-certification monitoring activities, including annual surveillances and unannounced audits, ensure your QMS remains effective. Our role includes verifying the ongoing requirements for Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Periodic Safety Update Reports (PSURs) are met by the clients, transforming continuous compliance from a challenge into a manageable and predictable business process.