EU IVDR Summary of Safety and Performance: Article 29 Content and EUDAMED Upload

1. Key takeaways

The Summary of Safety and Performance (SSP) is a mandatory public document for Class C and Class D devices, except devices used in performance studies, under Article 29(1). The SSP draft is one of the documents submitted to the notified body involved in the conformity assessment; the draft is validated by that body and, after validation, uploaded to EUDAMED by the notified body and made accessible to the public. The manufacturer must state in the label or the instructions for use where the SSP may be obtained. The SSP contains at least the eight items (a) to (h) of Article 29(2).

Because the SSP is validated by the notified body and uploaded by the notified body, the manufacturer does not control the final publication step, and project planning must account for that external dependency. The SSP is also an external-facing text: its audience is the intended user and, where relevant, the patient, which places writing style, not only content completeness, at the centre of the review.

2. Legal basis

3. Expert insights

Insight 1: The SSP is an external-facing text, and its readers are the intended users and patients.

The second subparagraph of Article 29(1) requires the SSP to be written in a way that is clear and understandable to the intended user and, where relevant, to the patient. This reader profile is entirely different from the reviewer of a performance evaluation report, who is a regulatory professional. Compressing sections of the performance evaluation report directly into the SSP typically leads to rejection by the notified body on readability grounds: dense statistical reporting, internal abbreviations and dossier cross-references do not serve the intended audience. The working approach is to translate, not to excerpt: take the conclusions of the performance evaluation and rewrite them in plain language, keeping the technical claims accurate but the sentences short and the structure transparent.

Insight 2: Three of the eight items of minimum content are the ones most often missing.

The items (a) to (h) of Article 29(2) are: device and manufacturer identification, including the Basic UDI-DI and, where issued, the SRN; the intended purpose and any indications, contraindications and target populations; the device description, including previous generations or variants and their differences, accessories and other devices and products intended to be used in combination; the harmonised standards and common specifications applied; the summary of the performance evaluation and information on the PMPF; the metrological traceability of the values assigned by the device; the profile and training suggested for users; and the residual risks, undesirable effects, warnings and precautions. The three items most frequently found missing in practice are (f) the metrological traceability, (g) the user profile and training and the SRN within item (a). Checking these three first saves review rounds.

Insight 3: The uploading party is the notified body, not the manufacturer.

The wording of the third subparagraph of Article 29(1) is that after its validation, the notified body shall upload the summary to EUDAMED. The obligations of the manufacturer are to prepare the draft and to state in the label or instructions for use where the SSP may be obtained. This differs from the logic of other EUDAMED modules, where the manufacturer submits the data itself, and it means the publication timeline depends on the notified body’s internal processing. Sponsors should agree the SSP validation and upload steps with the notified body as early as possible, put them into the project schedule, and treat the confirmation of the public availability of the SSP in EUDAMED as a closing milestone of the certification project rather than an afterthought.

Insight 4: The SSP is linked to the Class D review mechanism.

Under Article 50(1), when a notified body notifies a Class D certificate, it submits the SSP of Article 29 together with the notification. The SSP therefore enters the sight of the competent authorities and, where applicable, the MDCG, and Article 50(3) allows the MDCG and the Commission, on the basis of a reasonable concern regarding the safety and performance of any device, to consult a panel of experts for a scientific opinion. For Class D products, the SSP is thus not merely a public description: it is an input to the consultative review mechanism at Union level, and its content should be drafted with the awareness that expert reviewers beyond the notified body may read it.

4. Practical recommendations

1. Build the SSP template around the eight items of Article 29(2) and translate the conclusions of the performance evaluation into language addressed to the intended user and the patient.
2. Agree the SSP validation and upload schedule with the notified body early and include those steps in the project timeline as external dependencies.
3. State in the label and the instructions for use where the SSP may be obtained, as required by the fourth subparagraph of Article 29(1).
4. Establish an SSP update mechanism in line with the third subparagraph of Article 56(6), which requires the SSP to be updated as soon as necessary, and link it to the annual update cycle of the performance evaluation report.
5. Verify the public status and version consistency of the SSP in EUDAMED, in particular after the first four modules become mandatory from 2026-05-28.

5. Verification checklist

• □ It has been confirmed that the product is Class C or Class D, which determines whether the SSP is mandatory
• □ The SSP covers the eight items (a) to (h) of Article 29(2)
• □ The SSP language is clear and understandable to the intended user and the patient under Article 29(1)
• □ The validation and upload schedule to EUDAMED has been agreed with the notified body
• □ The label or the instructions for use state where the SSP may be obtained
• □ The SSP update mechanism is linked to the annual performance evaluation report update under Article 56(6)

GRZAN supports manufacturers entering or operating in the EU in vitro diagnostic market with Summary of Safety and Performance services under the IVDR: SSP drafting against the eight items of Article 29(2), readability reviews for intended users and patients, coordination with notified bodies on validation and EUDAMED upload, and update mechanisms linked to the performance evaluation report. Contact us at info@grzanglobal.com for SSP support.

Legal information verified as of 29 October 2026.