MDR Article 32

Article 32

Summary of safety and clinical performance

1. For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.

The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.

The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available.

2. The summary of safety and clinical performance shall include at least the following aspects:

(a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;

(b) the intended purpose of the device and any indications, contraindications and target populations;

(c) a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device;

(d) possible diagnostic or therapeutic alternatives;

(e) reference to any harmonised standards and CS applied;

(f) the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up;

(g) suggested profile and training for users;

(h) information on any residual risks and any undesirable effects, warnings and precautions.

3. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).

Explanation

What is SSCP in the MDR

SSCP stands for Summary of Safety and Clinical Performance. SSCP is a requirement applicable only to implantable and class III devices. Interestingly enough, the implants exempted from the implant card requirements, for example the sutures, staples, or dental fillings are NOT exempted from the requirement on SSCP.

SSCP and EUDAMED

As seen above, the requirement for Summary of Safety and Clinical Performance (SSCP) can be found in article 32. This may appear confusing because that is in the middle of all the requirements for registration in EUDAMED. The only reasonable explanation for why the requirement is found in article 32, would be that the manufacturer has to upload the SSCP information to EUDAMED and thereby make it publicly available.

SSCP requirements

The purpose of the SSCP is that the user and/or patient shall be informed about safety and clinical performance in a way they can understand. Therefore, it is mandatory for the manufacturer in these cases to include in labels or the instructions for use where to find the SSCP information.

There is also a good and well-structured MDCG document clarifying the SSCP requirements.

Please note that the notified body MUST review the SSCP as part of the conformity assessment procedure for those devices. And communication between the manufacturer and the notified body for this review is managed through EUDAMED. The manufacturer uploads its SSCP to EUDAMED, and then the notified body reviews it and uploads its review and summary to EUDAMED. The minimum content of the SSCP is found above in article 32.2.

Relevant courses

Find out more about the requirements by registering for the MDR course below:

Relevant templates

N/A

Applicable MDCG guidance documents

Relevant blog posts

YouTube videos

About the author

Pontus Gedda - Medical Device HQ instructor

Pontus Gedda

Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.

He has vast experience in the MDR and its implementation through hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.

He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.

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