EU MDR Transition: Common Gaps in Technical Documentation
Despite the extended transition timeline, many medical device manufacturers still have technical documentation that does not meet EU MDR standards. This article examines the most common gaps and the practical steps manufacturers can take to address them.
The Scale of the Transition Challenge
EU MDR 2017/745 represents the most significant regulatory change to the European medical device framework in over two decades. The transition from MDD 93/42/EEC and AIMDD 90/385/EEC introduced substantially more demanding requirements for clinical evidence, post-market clinical follow-up, risk management, device identification and quality management.
Notified Body capacity constraints, EUDAMED implementation delays and the disruption of the COVID-19 period all contributed to extended transition timelines. Despite multiple extensions, many manufacturers are working against Notified Body assessment queues while managing legacy technical documentation that was adequate under MDD but does not meet MDR requirements. The following gaps are the most consistently identified in MDR technical documentation reviews.
Clinical Evaluation Reports Not Meeting MDR Standards
EU MDR Article 61 and MEDDEV 2.7/1 Rev. 4 set out requirements for clinical evaluation that are substantially more demanding than the MDD approach of simply searching for clinical data and concluding it supports safety and performance. Under MDR, the clinical evaluation must be a rigorous, systematic review of clinical data relevant to the specific device, including a critical appraisal of the quality of that data. Common gaps: CERs structured as literature summaries rather than critical evaluations; insufficient justification of equivalence for devices relying on equivalent device data; no clear clinical benefit-risk assessment; and CERs not updated at the frequency required for the risk class.
PMCF Plans That Are Not Implemented
Post-Market Clinical Follow-up (PMCF) is a mandatory requirement under EU MDR for all devices unless the absence of PMCF is duly justified. Many manufacturers have written PMCF plans as part of their MDR technical file but have not implemented the activities described. Inspectors and Notified Bodies assess whether PMCF activities are actually generating data, whether that data is being analysed, and whether the PMCF evaluation feeds back into the clinical evaluation and risk management process. A PMCF plan that describes a registry study, literature survey or user survey that has not been initiated is a critical gap.
Biocompatibility Assessment Gaps
EU MDR requires biocompatibility assessment in accordance with ISO 10993. Under the revised ISO 10993-1:2018, the assessment framework shifted from a testing-first approach to a risk-based approach that requires a documented biological evaluation plan (BEP) and biological evaluation report (BER). Common gaps: biocompatibility data from legacy testing that predates ISO 10993-1:2018 and has not been reassessed against current standards; missing endpoints not historically required (e.g., degradation testing for resorbable materials); and no documented justification for endpoints not tested.
UDI Implementation Incomplete
Unique Device Identification (UDI) requirements under EU MDR have been phased in by device class. Class III and implantable devices were required from May 2021; Class IIa and IIb from May 2023; Class I from May 2025. Despite these deadlines, many manufacturers have incomplete UDI implementation, particularly for their full product range including all configurations, sizes and accessories. Common gaps: UDI-DI not registered in EUDAMED (given EUDAMED delays, alternative national databases have been used); Basic UDI-DI not established at the correct level; UDI carrier not correctly applied to labelling for all product configurations.
Risk Management Not Fully Integrated
EU MDR Annex I General Safety and Performance Requirements (GSPRs) require that risk management is conducted in accordance with ISO 14971 and that it is a continuous lifecycle process. Technical documentation assessments consistently identify risk management files that were created at product launch and not maintained through the product lifecycle. Post-market surveillance data must feed into risk management, new literature, complaint trends, incident reports and PMCF data should all be assessed for impact on the risk-benefit assessment. A risk management file that has not been updated since initial technical file creation does not demonstrate a functioning lifecycle risk management process.
Declaration of Conformity and Technical File Alignment
The Declaration of Conformity (DoC) under EU MDR must reference the specific MDR annexes against which conformity is claimed, list all applicable harmonised standards and common specifications, and identify the Notified Body and certificate number for Class IIa, IIb and III devices. Many manufacturers have DoCs that reference MDD annexes, do not list current applicable standards, or are not aligned to the current version of the technical documentation. The DoC is a public document and is frequently reviewed by inspectors as a first indicator of compliance status.
Prioritising the Remediation Effort
Manufacturers with large device portfolios cannot address all MDR technical documentation gaps simultaneously. A risk-based prioritisation approach, focusing first on the highest-risk devices and those closest to Notified Body assessment, is essential.
Independent technical documentation reviews can identify and prioritise gaps before Notified Body assessment, reducing the risk of major findings during the assessment process and the delays and costs associated with responding to them. The cost of remediating gaps identified in a pre-assessment review is consistently lower than remediating findings raised by a Notified Body during formal assessment.
Common MDR Documentation Gaps
- Clinical Evaluation Report
- PMCF Plan & Implementation
- Biocompatibility (ISO 10993)
- UDI Implementation
- Risk Management (ISO 14971)
- Declaration of Conformity
- GSPR Checklist
- Summary of Safety & Performance
EU MDR Technical Documentation Review
Sthira Assure conducts independent EU MDR technical documentation reviews and gap assessments before Notified Body submission.