EU MDR SSCP and Implant Card: Articles 32 and 18 Explained

1. Key takeaways

Under Article 32 of the MDR, manufacturers of Class III devices and implantable devices (other than custom-made and investigational devices) must prepare a summary of safety and clinical performance (SSCP), which is validated by the notified body involved in the conformity assessment. Under Article 18, manufacturers of implantable devices must supply, together with the device, an implant card and the information to be given to the patient, containing the device identification, warnings and precautions, and related items.

Both instruments serve transparency towards users and patients, but they work differently: the SSCP is a validated public document delivered through EUDAMED, while the implant card is a physical item delivered with each device. Neither can be produced as an afterthought once the device is on the market.

Operationally, the SSCP and the implant card belong to different work streams that must nevertheless stay consistent with each other and with the clinical evaluation. The SSCP states the clinical benefit and risk summary for the public; the implant card carries the identification that patients and clinicians need for traceability and adverse event reporting. Inconsistencies between the two, or between either of them and the instructions for use, are among the findings most frequently raised for implantable product lines.

2. Legal basis

The SSCP and implant card duties arise from Articles 32 and 18 of Regulation (EU) 2017/745, read with the related provisions listed below.

3. Expert insights

Insight 1: The SSCP is a public-facing document, not an abridged version of the technical documentation.

The legislative purpose of Article 32 is transparency. The SSCP must be written in a way that is understandable to the intended user, meaning a layperson, while still retaining the information that professionals need. The writing approach is therefore completely different from that of internal technical documentation: simply trimming the technical file down into an SSCP is a common failing approach (a practical estimate). Successful SSCPs are written from scratch for the lay reader, with technical detail relegated to clearly marked sections, and they are tested on non-specialist readers before submission for validation. A practical drafting method is to define the audience per section: patient-facing sections in plain language, professional sections with the necessary precision, and a glossary that keeps both groups aligned on the same terms.

Insight 2: The SSCP must be validated by the notified body; it is not published by the manufacturer alone.

Under Article 32, the SSCP is validated by the notified body involved in the conformity assessment of the device. This validation forms a pre-condition in the path to placing the device on the market, so SSCP preparation must be built into the project schedule and cannot be deferred until after market placement. Late SSCP preparation delays the certificate decision, and last-minute drafting almost always produces validation comments that cost more time than the drafting itself would have taken.

Insight 3: The SSCP connects to the publicly visible part of EUDAMED.

Under Article 33, EUDAMED includes a publicly accessible website. The SSCP is made available to the public through EUDAMED and is one of the core documents of the EU transparency mechanism. Companies must accept that the document is publicly searchable, and design it accordingly: confidential commercial information that is not required by the SSCP content requirements should not be written into the document, because once validated it can no longer be treated as internal material. Because the SSCP is public, every revision is also public: companies should treat each update as a small publication event, with version control and a change summary, rather than as an internal document edit.

Insight 4: The implant card is a physical document delivered to the patient together with the device.

Under Article 18, implantable devices must be accompanied by an implant card stating the device name, type, serial number or lot number and other identification, the manufacturer name and address, the authorised representative where applicable, and warnings and precautions. The implant card and the UDI system together form the traceability chain for implantable devices, which is also the reason the UDI carrier timetable under Article 123(3)(g) applied first to Class III and implantable devices. Packaging line checks should treat the implant card as a controlled component, not as marketing material. In practice the implant card is often the last item added to the packaging layout, which is exactly where identification errors happen. Giving it the same design control status as the label avoids reprint cycles and field corrections later.

4. Practical recommendations

The measures below organise the writing, validation and update cycle around the consistency requirement.

1. Schedule SSCP preparation and notified body validation as two separate milestones for Class III and implantable device projects.
2. Write the SSCP against the requirement of layperson understandability, while keeping the technical information sections that professionals need.
3. Establish a consistency check between the SSCP, the clinical evaluation report and the PSUR, so that conclusions always match.
4. Check the implant card content item by item against Article 18, and include it in packing list verification.
5. Synchronise the SSCP update mechanism with clinical evaluation updates and PSUR updates.

5. Verification checklist

Use the checklist below before submitting the SSCP for validation and before the release of any implantable batch.

• □ It has been determined whether the product falls within the scope of Article 32(1) (Class III or implantable)
• □ SSCP has been prepared and validated by the notified body (Article 32(4))
• □ SSCP writing approach meets the layperson understandability requirement
• □ SSCP conclusions are consistent with the clinical evaluation report and the PSUR
• □ Implant card has been prepared item by item against Article 18
• □ SSCP update mechanism is synchronised with clinical evaluation and PSUR updates

Regulatory information verified as of 29 October 2026.

GRZAN regulatory support. GRZAN assists medical device manufacturers with post-market compliance in the European Union market under Regulation (EU) 2017/745, covering SSCP preparation and validation support, implant card obligations, vigilance reporting, field safety corrective action (FSCA) recalls, and responses to competent authority inspections. If you need support with your EU MDR post-market obligations, contact info@grzanglobal.com.