The EU Medical Device Regulation, or EU MDR 2017/745, is the central European regulation for medical devices. It has progressively replaced the earlier Medical Device Directive (MDD) and AIMDD and sets out requirements for safety, performance, clinical evaluation, quality management and market surveillance. For manufacturers, authorised representatives, importers and distributors, the MDR fundamentally changes the evidentiary obligations and the depth of technical documentation.
For CROs, regulatory affairs teams and clinical operations, the MDR means: clinical evidence and post-market activities are becoming more formalised, and cooperation with Notified Bodies is coming even more sharply into focus. At the same time, the MDR is closely linked to the introduction of EUDAMED, UDI systems and new transparency requirements.
Scope, GSPR and clinical evidence
The MDR applies to medical devices and accessories, including certain products without a medical purpose, where they are listed in the annex to the MDR. It defines economic operators, their obligations, and the General Safety and Performance Requirements (GSPR). Manufacturers must demonstrate that a product is safe and delivers the claimed performance when used as intended.
A core element is the clinical evaluation. Manufacturers must systematically collect, assess and document clinical data to demonstrate conformity with the GSPR. Depending on the risk class, product novelty and available data, this may include literature data, equivalence arguments and/or clinical investigations. The MDR tightens the requirements for equivalence and, in many cases, demands more robust, product-specific data. The clinical evaluation is also a lifecycle process and must be continuously updated.
For project teams it is important that the clinical evidence matches the risk class, the intended purpose, and the claims made. If claims are later extended in marketing, this can trigger a need to update the clinical evaluation. Regulatory, clinical and market access/marketing functions should therefore be aligned early, so that the evidence strategy does not have to be “fixed” retrospectively.
Notified Body, conformity assessment and technical documentation
The MDR strengthens the role of the Notified Body. Depending on the risk class, a conformity assessment with more intensive review of the technical documentation is required. Manufacturers must, among other things, submit design dossiers, clinical data, usability evidence, software lifecycle documentation and a suitable quality management system. Additionally, requirements for the Person Responsible for Regulatory Compliance (PRRC) are set out.
In practice, considerable planning effort arises: resources for documentation, gap assessments, audits and cooperation with the Notified Body must be planned well in advance. Many delays result not from individual documents, but from inconsistent references and a lack of traceability across the entire technical documentation.
A common stumbling block is an unclear “evidence chain” between risk management, the GSPR checklist, the clinical evaluation and the post-market plan. Notified Bodies are increasingly scrutinising this coherence. Establishing a clean traceability structure early on (e.g. tables, a reference system, clear version control) reduces later requests for further information and speeds up reviews.
Post-market surveillance, vigilance and PMCF
The MDR requires a systematic post-market surveillance (PMS) system as well as, depending on the product, a PMCF programme (Post-Market Clinical Follow-up). PMS involves the continuous collection and evaluation of data from use, while PMCF specifically aims to further confirm clinical performance and safety after market launch. In addition, vigilance processes for reporting incidents and field safety corrective actions are regulated.
For manufacturers this means: the PMS plan, PMS report or Periodic Safety Update Report (for higher classes), trend reports and PMCF reports must be consistently interlinked. For CROs, this frequently creates project opportunities, e.g. the planning and conduct of PMCF studies or registry projects.
PMS is operationally often underestimated: data sources (complaint handling, service data, literature, registries, clinical follow-up) must be brought together in a consistent process. If these sources are not harmonised, gaps arise in trend analyses or in the traceability of decisions, which Notified Bodies typically address through queries.
UDI, EUDAMED and transparency requirements
The MDR introduces the UDI system (Unique Device Identification) to improve traceability. EUDAMED, as a European database, is intended to increase transparency regarding products, certificates, vigilance and clinical investigations. Although individual modules are being introduced in stages, it is important for manufacturers to align processes and data models early, so that product and quality data can be maintained consistently.
Additional effort often arises at interfaces: UDI labelling, general labelling, vigilance reporting, clinical data and technical documentation must fit together across roles, approvals and quality processes. If this integration is missing, Notified Bodies typically raise further requests, which can extend timelines toward certificate issuance.
A practical best-practice approach is to treat UDI/EUDAMED as part of master data management: clear data owners, defined approval workflows, and defined interfaces to ERP, QMS and complaint systems. This reduces data discontinuities and makes it easier to provide consistent product information across the entire lifecycle.
FAQ
What is the most important difference between the MDR and the earlier MDD?
The MDR significantly increases the requirements for clinical evidence, technical documentation and post-market processes, and strengthens oversight by Notified Bodies and authorities.
When are clinical investigations required under the MDR?
Clinical investigations may be required when the existing clinical data are insufficient, e.g. for new technologies, higher risk classes, or where equivalence cannot be convincingly demonstrated.
Which documents are central to post-market activities?
Central documents are the PMS plan, the PMS report or Periodic Safety Update Report, the PMCF plan and PMCF reports, as well as vigilance documentation and trend analyses.
Regulatory references (selection):
- Regulation (EU) 2017/745 on medical devices (MDR)
- MDCG guidelines (Medical Device Coordination Group) on the interpretation and implementation of the MDR
- ISO 13485: Quality management for medical devices (typically used as the QMS basis for MDR compliance)