The move from Directive 93/42/EEC (MDD) to Regulation (EU) 2017/745 (MDR) has brought about one of the biggest regulatory changes in the history of the medical device sector in Europe.
For manufacturers, the transition has not simply been a regulatory change, but a profound transformation in:
- technical documentation requirements,
- testing and validation requirements,
- clinical evaluation,
- post-marketing surveillance,
- and relationship with notified bodies.
In this article we answer the most frequently asked questions about the differences between MDR and MDD and explain how they directly affect the development and certification of medical devices.
What changes conceptually between MDD and MDR?
The MDD was a directive, which meant that each Member State transposed it into its national legislation. The MDR, on the other hand, is a regulation that is directly applicable in all European Union countries.
This involves:
- greater regulatory harmonization,
- less room for national interpretation,
- more stringent and homogeneous criteria.
The MDR introduces a much more focused approach to patient safety, traceability and continuous clinical evidence.
Main technical differences between MDD and MDR
1️⃣ More demanding in clinical evaluation
Under MDD, it was more common to rely on equivalences with products already on the market.
With the MDR:
- further clinical justification is required,
- access to equivalence data is more limited,
- the need for in-house testing is increasing.
This directly affects manufacturers of implantable products, where clinical evidence is critical.
2️⃣ Strengthening testing and technical validation
The MDR requires the manufacturer to demonstrate:
- mechanical performance,
- structural safety,
- biocompatibility,
- long-term stability.
Tests must be well documented and, in many cases, performed in ISO/IEC 17025 accredited laboratories to facilitate acceptance by notified bodies.
3️⃣ Reclassification of medical devices
Some products that under MDD were class I or IIa have been reclassified into higher classes under MDR, especially:
- implantable products,
- products that interact with the central nervous system,
- certain reusable products.
This reclassification implies more rigorous assessments and greater involvement of the notified body.
4️⃣ Increased post-marketing control
The MDR introduces enhanced requirements for:
- post-marketing clinical follow-up (PMCF),
- active surveillance,
- continuous risk analysis,
- updating of the technical file.
The manufacturer can no longer consider certification as an end point, but as a continuous process.
Real impact for manufacturers
The change from MDD to MDR has meant:
- increase in certification costs,
- longer preparation time of the technical dossier,
- need for additional testing,
- strategic planning earlier in the development of the medical device.
Manufacturers that integrate MDR requirements upstream reduce the risk of delays and retesting.
Role of accredited trials under MDR
Although the MDR does not explicitly mandate that all trials be accredited, in practice:
- notified bodies prioritize accredited tests,
- implantable products require particularly strong evidence,
- traceability and technical competence of the laboratory become more important.
Working with an accredited laboratory reduces observations and speeds up the CE marking process.
How Med-Lab IBV supports the MDR Transition
Med-Lab IBV accompanies manufacturers in:
- strategic trial planning under MDR,
- adaptation of technical documentation,
- execution of accredited mechanical and biomechanical tests,
- certification-oriented technical interpretation.
This approach makes it possible to transform regulatory compliance into a competitive advantage, rather than an obstacle.
