The Medical Device Directive (93/42/EEC)—known as the MDD—was the cornerstone regulation governing medical devices within the European Union for over two decades. It established a harmonized framework for ensuring the safety and performance of medical devices placed on the EU market. Although the MDD has been replaced by the Medical Device Regulation (MDR 2017/745), products certified under the MDD may still be legally placed on the market during the transitional period.
What Was the Medical Device Directive?
The MDD applied to a wide range of medical devices, from bandages and surgical instruments to diagnostic software and implantable devices. It defined a risk-based classification system (Class I, IIa, IIb, and III), and outlined procedures for conformity assessment, CE marking, and market surveillance.
It aimed to ensure that all medical devices sold in the EU were:
- Safe and effective for their intended use
- Properly labeled and documented
- Supported by clinical and technical data
MDD vs MDR: What Has Changed?
The Medical Device Regulation (EU) 2017/745 officially replaced the MDD on 26 May 2021. However, under transitional provisions (extended in Regulation (EU) 2023/607), some MDD-certified devices can remain on the market until 2028 or 2029, depending on their risk class and conditions.
Key differences introduced by the MDR include:
- More rigorous clinical evaluation and post-market surveillance
- Stricter requirements for notified bodies and conformity assessment
- Expanded scope (including software, reprocessed devices, cosmetic implantables)
- Unique Device Identification (UDI) system
- EUDAMED database for greater transparency
Essential Requirements under the MDD
Annex I of the MDD outlined Essential Requirements that devices had to meet, such as:
- Safety and performance under normal use
- Minimization of risks related to contamination, infection, and misuse
- Biocompatibility and risk management
- Clinical evaluation based on data and experience
- Adequate labeling and instructions for use
Manufacturers were required to carry out a risk assessment and demonstrate compliance with these requirements through appropriate testing and documentation.
Conformity Assessment and CE Marking under the MDD
Depending on the classification of the device, different conformity assessment procedures applied:
- Class I: Self-declaration by the manufacturer
- Class IIa, IIb, and III: Required the involvement of a Notified Body for auditing and certification
All devices had to:
- Undergo appropriate testing and clinical evaluation
- Prepare a technical file with design, test, and safety documentation
- Issue an EU Declaration of Conformity
- Affix the CE mark, including the Notified Body number (if applicable)
Harmonised Standards and Presumption of Conformity
Using relevant harmonised European standards (EN ISO standards) helped manufacturers demonstrate compliance with the MDD’s Essential Requirements. Common standards included:
- EN ISO 13485: Quality management systems for medical devices
- EN ISO 14971: Risk management
- EN 60601 series: Safety of electrical medical equipment
- EN 62366: Usability engineering for medical devices
Responsibilities of Economic Operators
Under the MDD, manufacturers, authorised representatives, importers, and distributors had defined responsibilities, including:
- Ensuring CE marking and documentation are in place
- Retaining technical documentation
- Reporting serious incidents and field safety corrective actions
- Cooperating with national competent authorities
Contact Us
As the EU transitions fully from the MDD to the MDR, understanding legacy requirements and new obligations is critical for maintaining compliance and market access. Whether you're managing MDD certificates under transitional provisions or preparing for MDR conformity, our expert team can help you navigate clinical evaluation, risk management, technical documentation, and notified body coordination.
Contact us today to ensure your medical devices meet all EU regulatory requirements—past and present—with confidence and clarity.
