The Summary of Safety and Clinical Performance is a public-facing document with two very different target audiences, each requiring a fundamentally different writing approach. Getting the balance right — rigorous enough for healthcare professional reviewers, accessible enough for patients — is the main challenge of SSCP writing, and it is where most first drafts fall short.

Regulatory requirements and when the SSCP applies

Under EU MDR Article 32, an SSCP is required for all Class III implantable devices and for Class IIb active implantable devices (other than those addressed by Directive 90/385/EEC). Notified Bodies validate SSCPs as part of the conformity assessment, and once certified, the SSCP must be publicly accessible via EUDAMED. It must be updated whenever the clinical evaluation is updated, and at minimum annually for Class III devices.

The SSCP must be drafted in at least one official EU language. Teams operating across multiple EU markets typically need translations — factor this into planning timelines.

The HCP section: rigour without unnecessary complexity

The healthcare professional section of the SSCP should closely mirror the structure of the CER's benefit-risk analysis, adapted for a summary format. Required elements include:

  • Device description, intended purpose, and target patient population
  • Summary of clinical benefits and supporting clinical evidence
  • Summary of residual risks and the methods used to minimise them
  • Benefit-risk conclusion
  • Reference to the PMCF programme and a summary of its current status
  • Any contraindications, precautions, or warnings relevant to clinical decision-making

The HCP section should be technically precise and fully consistent with the CER, IFU, and risk management file. Reviewers — including Notified Body staff — will check for alignment. Any benefit or risk described in the SSCP that is not documented in the CER or IFU will generate a comment.

The patient section: plain language as a technical requirement

The patient section is not a simplified version of the HCP section — it is a standalone summary written for a reader with no assumed clinical knowledge. MDCG 2019-9 provides guidance on format, but the core requirement is readability: the patient must be able to understand what the device does, what the known risks are, and what clinical benefits it provides, in language that does not require medical training.

Common failures in patient sections include:

  • Medical terminology without plain-language equivalents
  • Excessive technical detail from the HCP section transposed without adaptation
  • Benefit statements that match the clinical evidence but are not meaningful to a patient
  • Risk statements that are technically accurate but fail to contextualise what the risk means in practice

Plain-language review — assessing readability with a recognised framework or with input from lay reviewers — is not formally mandated but prevents the most common patient section problems before Notified Body validation.

Alignment with the CER, PMCF Evaluation Report, and IFU

The SSCP must be consistent with the CER at the time of submission. It cannot reflect a more favourable benefit-risk picture than the CER supports, and it cannot omit residual risks that the CER identifies. For teams managing an annual documentation update cycle, the SSCP update should be triggered by the CER update — not treated as a separate workstream.

Clinical claims in the SSCP should also be checked against the IFU. If a clinical benefit is stated in the SSCP that is not reflected in the IFU's intended purpose or indications for use, that creates a labelling consistency issue that will require resolution before Notified Body validation.

Planning for EUDAMED publication

Once certified, the SSCP is published on EUDAMED and is publicly accessible. This places an additional obligation on the writing: beyond regulatory accuracy, the document must be suitable for public access. Sensitive commercial information should not appear in the SSCP, and the patient section in particular should be written with the awareness that it will be read by patients, advocacy groups, and the general public — not just regulatory reviewers.