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FAQEU

Which devices need an EU MDR SSCP?

Medical-device regulatory, clinical, quality, and technical-documentation teams can use this page to apply Article 32 and define the required SSCP content.

Every implantable or class III device needs an SSCP unless it is custom-made or investigational. The device's intended purpose and Annex VIII classification still control the decision.

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Author
Sorena AI
Published
May 9, 2026
Updated
Jul 23, 2026
Questions
6

Structured answer sets in this page tree.

Primary sources
6

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 23, 2026
Overview

A Summary of Safety and Clinical Performance () is a public document for intended users and, when relevant, patients. Use three checks: determine whether the device is implantable, apply Annex VIII to determine whether a non- is , and check whether it is or . Every implantable or class III device needs an SSCP unless one of those exclusions applies. Use this page to scope and control the work. A specific device still needs a documented classification and, for a borderline case, device-specific regulatory advice.

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Question 1

Which devices need an SSCP?

First check whether the device is implantable. Article 2(5) covers a device intended to be introduced completely into the body, or to replace an epithelial surface or the surface of the eye, by clinical intervention and remain after the procedure. It also covers a device introduced partially by clinical intervention that is intended to remain for at least 30 days. Implantable devices can be class IIa, IIb, or III, and all three groups need an .

If the device is not implantable, check whether it is . The manufacturer classifies the device from its intended purpose and the rules in Annex VIII. When several rules or sub-rules apply, the one producing the highest class controls. The technical documentation must record the selected rule and the reason it applies.

routes include certain devices used in direct contact with the heart, central circulatory system, or central nervous system; active implants and devices that control or monitor them; breast implants and surgical meshes; total or partial joint replacements; spinal disc replacements and implants that contact the spinal column; diagnostic or therapeutic decision software whose output could lead to death or irreversible deterioration; devices that incorporate a medicinal substance with an ancillary action; certain tissue-derived, nanomaterial, and systemically absorbed substance-based devices; and active therapeutic devices such as closed-loop systems or automated external defibrillators. Annex VIII contains the complete rules.

Examples in MDCG classification guidance include prosthetic heart valves, vascular stents, cochlear implants and their accessories, breast implants, surgical meshes, total or partial joint replacements, software used to make treatment decisions for acute stroke, antibiotic bone cement, automated external defibrillators, and automated closed-loop insulin-delivery systems. Classification still depends on the intended purpose and applicable rule for the specific device.

Under Rule 8, some ancillary joint or spinal components, including certain screws, wedges, plates, and instruments, remain outside . The component still needs an if it meets the definition of an .

The gives the public an updated summary of the device's clinical data, safety, and clinical performance. The instructions for use, implant card, and advice from a healthcare professional remain separate, and the SSCP must be free of promotional claims.

  • Manufacturer: prepare the from the current technical documentation, keep it accurate, manage translations, and confirm that the required versions are available before placing the device on a Member State market. For updates containing new or changed information other than strictly editorial modifications, MDCG guidance says the manufacturer should submit the updated SSCP to the with the required .
  • : independently assess the device for conformity with the MDR, validate the against the required content and current technical documentation, and complete the upload step assigned to it under the applicable transition process.
  • : make the public and link it to the , the identifier used to connect the SSCP to the relevant device group. As of 23 July 2026, the first four EUDAMED modules have been mandatory since 28 May 2026. MDCG 2026-4 sets temporary SSCP upload arrangements while new functionality is introduced, so teams should record who must upload each version and whether the published revision has been validated.

Which devices need an under the EU MDR?

An implantable or device needs an unless it is or . First, determine whether the device meets the EU MDR definition of an ; an implantable class IIa or IIb device still needs an SSCP. For a non-implantable device, apply the Annex VIII classification rules and prepare an SSCP if the rules place it in class III.

What does the EU MDR mean by an ?

An is intended to be introduced completely into the body, or to replace an epithelial surface or the surface of the eye, by clinical intervention and remain after the procedure. A device intended to be introduced partially by clinical intervention and remain for at least 30 days also counts as implantable. Implantable devices in class IIa, IIb, or III fall within the requirement unless they are or .

What counts as a device for the requirement?

is the highest EU MDR risk class. Apply every relevant Annex VIII rule to the device's intended purpose and characteristics; the rule producing the highest class controls. Examples include prosthetic heart valves, vascular stents, cochlear implants, breast implants, surgical meshes, total or partial joint replacements, specified spinal implants, software used for acute-stroke treatment decisions, antibiotic bone cement, automated external defibrillators, and automated closed-loop insulin-delivery systems. Other class III routes cover certain tissue-derived, nanomaterial, and systemically absorbed substance-based devices. Classification depends on the intended purpose and exact Annex VIII rule, which the technical documentation must identify.

What should an EU MDR include?

Cover eleven content groups: device and manufacturer identity; ; the manufacturer's Single Registration Number, if issued; intended purpose and patient population; device description and relevant variants; risks, undesirable effects, warnings, and precautions; and results; diagnostic or therapeutic alternatives; intended-user profile and training; applied harmonised standards and common specifications; and revision history. The detailed checklist below shows what belongs in each group.

Who prepares, validates, and publishes the ?

The manufacturer prepares and maintains the . A validates it against the MDR requirements and current technical documentation. As of 23 July 2026, MDCG 2026-4 assigns temporary upload steps while new functionality is introduced. For a new certificate registered from 28 May 2026, the notified body uploads the master SSCP with the certificate. For devices placed on the market before that mandatory-use date, manufacturers should upload the applicable SSCPs as soon as the new functionality permits and no later than 27 February 2027. The guidance describes a later move to manufacturer uploads of the master SSCP and translations when the new functionality is available.

How should a manufacturer control quality and updates?

The manufacturer is responsible for the and chooses which internal team owns the work. Source the content from current technical documentation, assign the SSCP a unique reference number, and keep it objective, readable, and free of promotional claims. Review it when the post-market clinical follow-up () evaluation report and periodic safety update report () are updated. Revise any section that is incorrect, incomplete, or out of step with the technical documentation. Record the revision, validation status, and validated language; control translation accuracy through the quality management system; and, for updates containing new or changed information other than strictly editorial modifications, MDCG guidance says the manufacturer should submit the updated SSCP to the with the required PSUR.

Where should users and patients find the ?

Article 32 requires the manufacturer to state on the label or in the instructions for use where the is available. The public version is linked in through the . The SSCP does not replace the label, instructions for use, implant card, or advice from a healthcare professional.

When does an need to be updated?

Review the whenever the evaluation report and are updated and whenever new information makes a public statement incorrect or incomplete. Common triggers include changed indications or contraindications, new residual risks or undesirable effects, revised clinical-evaluation conclusions, important vigilance or trend findings, corrective actions, and changes to the device or intended purpose that affect the summary. Record each revision and its validation status. For an update containing new or changed information other than strictly editorial modifications, MDCG guidance says the manufacturer should submit the updated SSCP to the with the required PSUR.

How should translations be controlled?

Provide the in the languages required by each Member State where the device is made available. Keep the master and translated versions under document control, verify translation accuracy through the quality management system, identify the validated language, and ensure each public version matches the current validated content. Follow the applicable transition process for uploading the master SSCP and translations.

When does an need a separate patient-facing part?

The always needs information for intended users or healthcare professionals. MDCG 2019-9 Rev.1 recommends a separate patient-facing part when the information is relevant to patients, especially for implantable devices supplied with implant cards and devices used directly by patients. Eligible Annex XVI devices should also be treated as relevant for patient information. Write the patient part in plain language, explain medical terms, and keep it separate from the professional section so each audience can find the appropriate level of detail.

Citations
Question 2

How do you decide whether a device needs an SSCP?

Work through the trigger in order. Start with the Article 2(5) implantable-device definition because an implantable class IIa or IIb device still needs an . If the device is not implantable, apply every relevant Annex VIII rule and use the highest resulting class. Then check whether the device is or , because Article 32 excludes both.

Classify from the intended purpose and device characteristics, then record the duration of use, invasiveness, anatomical site, active or software function, materials, and every rule considered. The worked cases show the reasoning pattern. The manufacturer still needs a device-specific classification rationale.

  • Case 1 - class IIa diagnostic ultrasound system: it is not implantable and Annex VIII does not place it in . Result: Article 32 does not require an .
  • Case 2 - class IIb dental implant: it meets the Article 2(5) implantable-device definition. Result: it needs an even though it is not .
  • Case 3 - automated external defibrillator: it is not implanted, but the applicable Annex VIII rule places it in class III. Result: it needs an .
  • Case 4 - : it meets the implantable definition, but Article 32 expressly excludes custom-made devices. Result: Article 32 does not require an .
  • Case 5 - device: its class would ordinarily trigger an , but Article 32 excludes investigational devices. Result: no Article 32 SSCP is required while that exclusion applies; the clinical-investigation requirements remain separate.
Citations
Question 3

What must an SSCP contain?

Use controlled technical documentation for every statement. MDCG 2019-9 Rev.1 organises the public summary around the content groups below. Keep the wording objective and understandable to the intended user, and leave out promotional claims.

  • Device and manufacturer identity: device and trade names, manufacturer name and address, Single Registration Number if issued, , medical-device nomenclature description, risk class, year of first CE marking, authorised representative when applicable, and notified-body name and identification number.
  • Intended purpose: indications, contraindications, target populations, intended users, and any required training.
  • Device description: operating principles, key components and materials, accessories intended to be used with the device, and relevant previous generations or variants.
  • Risks and safety information: residual risks, undesirable effects, warnings, precautions, and other relevant safety information that remains after risk controls.
  • Clinical evidence: the clinical-evaluation summary, the type and amount of supporting data, both favourable and unfavourable findings, and relevant results.
  • Therapeutic or diagnostic alternatives: available alternatives and the circumstances relevant to choosing among them.
  • Standards and specifications: applied harmonised standards and common specifications.
  • Revision control: reference number, issue date, revision description, validated language, notified-body validation status, and the versions and translations made public.
Citations
Question 4

What products fall into each EU MDR class?

The MDR does not assign a permanent class to a product name. The manufacturer applies Annex VIII to the device's intended purpose, duration of use, invasiveness, anatomy, materials, software impact, and other characteristics. The examples below show common classifications from MDCG 2021-24 Rev.1; a specific device may classify differently when its intended purpose or characteristics differ.

For this question, class I devices are outside Article 32. Class IIa and IIb devices need an SSCP only when they meet the definition of an . Every device needs an SSCP, whether implantable or not, unless it is or .

  • Class I: examples include manual wheelchairs, walking aids, stethoscopes, corrective spectacle frames, simple wound dressings, examination lamps, and software that falls outside the higher Rule 11 categories. These devices do not need an under Article 32.
  • Class IIa: examples include short-term corrective contact lenses, needles and syringes, infusion tubing, diagnostic ultrasound systems, electrocardiographs, feeding pumps, and X-ray image detectors. Rule 8 also places certain devices intended to be placed in the teeth in class IIa, with MDCG examples including bridges, crowns, dental filling materials, and dental pins. A class IIa device needs an only if the specific device meets the Article 2(5) implantable-device definition.
  • Class IIb: examples include blood bags, haemodialysers, long-term urinary catheters, apnoea monitors, diagnostic X-ray and computed-tomography systems, and contact-lens disinfectants. Rule 8 examples of class IIb implantable devices include dental implants and abutments, artificial ligaments, shunts, peripheral stents and valves, plates, intra-ocular lenses, non-absorbable sutures, penile implants, and pedicle screws. These implantable class IIb devices need an .
  • : examples include prosthetic heart valves, central vascular stents and long-term catheters, cochlear implants, implantable pacemakers and defibrillators, breast implants, surgical meshes, total or partial joint replacements, specified spinal implants, software used for acute-stroke treatment decisions, antibiotic bone cement, automated external defibrillators, and automated closed-loop insulin-delivery systems. Every class III device needs an unless it is or .

Do all class IIa and IIb devices need an ?

No. A class IIa or IIb device needs an only when it meets the Article 2(5) definition of an . For example, a diagnostic ultrasound system may be class IIa and a computed-tomography system may be class IIb, but neither needs an SSCP merely because of that class. Dental implants, intra-ocular lenses, peripheral stents, plates, and other implantable class IIb devices do need one.

Are all products with the same name in the same MDR class?

Classification depends on the device's intended purpose and characteristics. Duration of use, invasiveness, anatomical site, biological effect, absorption, medicinal substances, nanomaterials, and the clinical impact of software can change the applicable Annex VIII rule. Use product examples for orientation, then document the exact rule and rationale for the specific device.

Citations
Question 5

What evidence should support the SSCP?

Source the from the device's technical documentation: the controlled evidence set that shows how the device meets the MDR. Keep a traceable record showing the source for each public statement and confirming that it still matches the current technical documentation.

For the clinical section, retain the plan and report, the evidence used to support conformity, both favourable and unfavourable clinical data, and the post-market clinical follow-up () plan and evaluation report. If the clinical evaluation relies on equivalence to another device, retain the equivalence rationale and evidence showing that the manufacturer has sufficient access to the equivalent device's data.

  • Identification and scope: classification rationale, implantable-status rationale, intended purpose, label and instructions-for-use references, , manufacturer Single Registration Number, notified-body name and identification number, and the reference number.
  • Safety and clinical evidence: risk management file, design verification and validation reports, report, post-market surveillance plan, plan and reports, inputs, vigilance or trend evidence, and instructions-for-use cross-references.
  • Document control: issue dates, change descriptions, validated language, notified-body validation status, translations sent to the , and checks confirming publication in .
Citations
Recommended next step

Keep the SSCP tied to its evidence

Track each SSCP statement against the current technical documentation, with an owner, review date, revision status, and notified-body validation record.

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Question 6

How was this guide prepared and reviewed?

Sorena AI assembled this page from Regulation (EU) 2017/745, MDCG 2019-9 Rev.1, MDCG 2021-24 Rev.1, MDCG 2026-4, and the European Commission's overview. Each statement about eligibility, classification, content, evidence, publication, and updates was mapped to those sources. Repeated explanations were combined into standalone answers and worked cases.

AI assisted with source comparison, drafting, and organisation. Readers can use the citations to check each conclusion against the controlling regulation and current Commission guidance. No named human regulatory or clinical reviewer is claimed. For a specific device, confirm the intended purpose, classification rationale, notified-body instructions, applicable Member State language requirements, and current process before acting.

Source review current as of 23 July 2026. This revision added the standalone decision test, class-based worked cases, a scannable content checklist, translation and lifecycle answers, internal reading paths, and the June 2026 transition guidance. The page date reflects those substantive changes.

Citations
Regulation (EU) 2017/745 on medical devices

Binding source. Article 2 provides definitions, Article 32 governs the SSCP, Article 51 and Annex VIII govern classification, Article 86 governs PSURs, and Annex XIV governs clinical evaluation and PMCF.

EUDAMED overview

Commission source used for EUDAMED purpose, module scope, and mandatory-use date.

Primary sources

References and citations

EUDAMED - European Database on Medical Devices
health.ec.europa.eu
Referenced sections
  • Commission overview for the public database context, module scope, and mandatory use of the first four modules from 28 May 2026.
"enhance overall transparency"
EUDAMED overview
health.ec.europa.eu
Referenced sections
  • Commission source used for EUDAMED purpose, module scope, and mandatory-use date.
"mandatory from 28 May 2026"
Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • Binding source. Article 2 provides definitions, Article 32 governs the SSCP, Article 51 and Annex VIII govern classification, Article 86 governs PSURs, and Annex XIV governs clinical evaluation and PMCF.
"summary of safety and clinical performance"
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