Technical Documentation for Medical Devices: Which Preclinical Deliverables Are Typically Required

The technical documentation for medical devices is the central evidence package for CE marking under the Medical Device Regulation (MDR) 2017/745. It is used to demonstrate to the Notified Body that a product meets the General Safety and Performance Requirements (GSPR) throughout the product lifecycle. Particularly critical in the conformity assessment procedure: preclinical data. Missing or inadequately classified preclinical data can lead to inquiries, additional requests, and delays in the conformity assessment.

The risk: Missing or misclassified preclinical evidence in technical documentation

Many manufacturers underestimate just how detailed the regulatory expectations for medical device documentation have become. The Medical Device Regulation (MDR) 2017/745 sets more detailed expectations than the former Medical Device Directive (MDD). Technical documentation that merely attaches preclinical studies as an appendix without systematically linking them to the GSPR is often assessed during Notified Body review as insufficiently traceable.

Common Notified Body findings — and what is usually acceptable

Notified Body reviews frequently show recurring patterns that trigger inquiries or additional requests:

01	Lack of traceability Lack of traceability between the risk management file (ISO 14971), the GSPR checklist, and verification results: the alignment among these three elements is typically considered a key assessment criterion in reviews by Notified Bodies.
02	Unevaluated protocol deviations Protocol deviations in study reports that have not been commented on or evaluated.
03	Imprecise GSPR checklists GSPR checklists without references to applicable standards and without a precise identification of the test sections containing the evidence.
04	Misclassified preclinical data Data from preclinical tests that are incorrectly reported in the Clinical Evaluation Report (CER) as clinical evidence pursuant to Article 2(51) of the MDR.

Technically justified strategies for addressing remaining clinical issues may be acceptable if they are actively addressed by a robust PMCF plan or, in strictly limited cases, justified on a product-specific basis in accordance with Article 61(10) of the MDR. Transparency alone is generally not sufficient; what is crucial is that deviations are evaluated, classified on a risk-based basis, and, if necessary, addressed with appropriate measures.

Context: Where preclinical data are incorporated into the technical documentation

The MDR structures the technical documentation through Annexes II and III. Annex II governs the basic documentation, ranging from the product description to verification and validation. Annex III defines the requirements for post-market surveillance. For preclinical data, Annex II, Section 6 is particularly relevant.

MDR Annex II, Section 6: Key Section for Verification and Validation

Section 6 of MDR Annex II requires verification and validation evidence to be documented. Here, the preclinical evidence must be clearly identified and referenced within the verification and validation documentation:

• Biocompatibility tests according to ISO 10993
• EMC testing
• Software verification and validation activities aligned with IEC 62304
• Sterilization validations
• Stability studies

The key is to systematically link these requirements to the essential safety and performance requirements (GSPR) set forth in Annex I of the MDR.

GSPR Mapping: How Preclinical Evidence Addresses the Requirements

For each applicable GSPR from Annex I of the MDR, the technical documentation must contain the corresponding verification or validation evidence. This may be a preclinical study, but it does not have to be. What matters is the evidence package itself: including justification of the test method, traceable acceptance criteria, and risk-based derivation in accordance with risk management. Mapping — from the GSPR through the evidence to the specific section in the study report — is the core of traceability. If it is missing, the Notified Body cannot verify whether the regulatory requirements have been fully addressed.

Clinical Evaluation Report and Preclinical Evidence: What Can — and Cannot — Be Counted

Preclinical data may be used in the CER (Clinical Evaluation Report) to assess safety and performance, but it generally does not replace clinical data or clinical evidence in the regulatory sense.

A common mistake: Manufacturers present laboratory results as part of the clinical evaluation as clinical evidence pursuant to Article 2(51) of the MDR. This often leads to Notified Body questions or findings.

In very limited circumstances, Article 61(10) MDR may allow a product-specific justification that clinical data are not appropriate. However, this justification must be developed on a product-specific basis and applied restrictively.

Preclinical work products: What the CRO delivers and what belongs in the technical documentation

In the context of preclinical studies, manufacturers frequently collaborate with contract research organizations (CROs). The division of labor must be clearly defined in both the contract and the study documentation. Pursuant to Article 10 of the MDR, the manufacturer bears legal responsibility for the conformity of its products.

Study plan and protocol: Evidence of methodological planning prior to implementation

The protocol demonstrates to the Notified Body that the study was methodologically planned before data were collected. It must establish endpoint definitions, acceptance criteria, the exact version of the standard applied, and the reference to the respective GSPR requirement.

Raw data overview and deviation logic: What Notified Bodies typically expect

To make study reports verifiable, traceable raw data documentation with documented deviation management is often of high relevance. Protocol deviations must be evaluated and commented on in the final report.

Final study report: What it must demonstrate for Notified Body review

The final study report is a key deliverable; however, its validity also depends on the protocol, deviation assessment, and traceable integration into the technical documentation. It must be complete, cite applicable standards, and be transparent in its presentation of limitations. A report that does not specify the standards applied, does not assess deviations, or does not include GSPR classification may be evaluated during review as insufficiently robust or incomplete.

Checklist: Manufacturer Inputs vs. CRO Work Products

Manufacturer (sponsor) provides	CRO provides
Product description with intended use and risk class	Study plan and detailed protocol
Regulatory objective and acceptance criteria	Raw data archiving in accordance with study- and quality system-specific requirements, as well as ensuring the manufacturer’s access to relevant documents
GSPR draft and standard specifications	Deviation management documentation
Study design sign-off, risk-based CRO qualification, or audit decision	Final study report

Common reasons for additional requests from the Notified Body

Missing standard references and unclear endpoint definitions

Study reports that do not specify the standards applied, including exact version numbers, are among the most common reasons for inquiries and additional requests. The same applies to endpoints that were not clearly defined in the protocol, as well as to acceptance criteria that were subsequently modified.

Incomplete GSPR mapping and lack of traceability

If the link between preclinical evidence and GSPR requirements is missing, or if the checklist refers only to a general document rather than to the specific section, this significantly complicates the review process and often leads to inquiries or additional requirements. Manufacturers who involve Regulatory Affairs early in the study planning process can significantly reduce the risk of these additional requirements.

Frequently Asked Questions About Technical Documentation for Medical Devices

Who is responsible for integrating the study report into the technical documentation: the CRO or the manufacturer?

The responsibility lies solely with the manufacturer. The CRO provides the document; the manufacturer bears regulatory responsibility under Article 10 of the MDR for its correct inclusion in the technical documentation and its linkage to the GSPR.

Does the technical documentation have to include the complete study report?

The technical documentation must fully and transparently reflect the underlying evidence. Whether the complete study report is included in the dossier itself or referenced elsewhere should be evaluated based on the documentation architecture and auditability. It is essential that standard references, deviations, and the verifiable classification of the evidence are available for review.

What is the difference between technical documentation (MDR) and a Design History File (FDA)?

Technical documentation is the European concept under MDR 2017/745 (Annexes II and III); the Design History File originates from the U.S. quality system context under FDA 21 CFR Part 820 and documents the development history within the framework of design controls. Both document product development but follow different structural guidelines and regulatory requirements.

How long must technical documentation and associated evidence, including preclinical study documents, be retained?

The MDR specifies clear retention periods in Article 10(8): at least 10 years for general medical devices and at least 15 years for implantable devices, in each case starting from the date of placing on the market of the last product covered by the respective declaration of conformity. The preclinical study documents relevant to the current evidence base and technical documentation should be kept available in a complete, legible, and traceable form.

Next step: Clarify your evidence strategy in 30 minutes

Sources & further links

External references

• FDA – 21 CFR Part 820: Quality Management System Regulation
• EU MDR 2017/745

Internal links

• Medical Device Regulation: Overview of MDR documentation requirements
• Preclinical Data: The data package as a core building block of the Technical File
• Medical Device Compliance under the EU MDR: Documentation compliance under MDR
• PMCF: The PMCF plan as part of the Technical Documentation
• GLP-compliant practices: GLP-compliant documentation as the basis for the study report
• Class III Medical Devices: Extended documentation requirements for high-risk products

As of: May 2026 | Last reviewed: May 2026