Summary of Safety and

Clinical Performance
(SSCP) in a nutshell (1/4)

Summary of Safety and Clinical Performance under EU-MDR

 Art. 32: The SSCP is intended to provide public

access to an updated summary of clinical data and
other information about the safety and clinical
performance of a medical device.
 It is only applicable to implantable devices (IIa as
well) and class III devices, other than custom-made
or investigational devices
 Key role in the post-market clinical follow-up –
aligned at all times with TechDoc
 For the following devices, the SSCP will have a part
intended for patients:
 implantable devices for which patients
will be given implant cards
 class III devices that are intended to be
used directly by patients.
 Devices listed in MDR Annex XVI
 The SSCP has to be validated by the Notified
Body (NB) – refer to MDCG 2019-9
 When EUDAMED is made available, SSCPs will be
publicly available
Translations to EU languages
 the SSCP should be translated into the languages
accepted in the Member States where the device is
envisaged to be sold similarly to IFU [Annex II (2), Art.
10, par. 11]
 Translation in English is mandatory

Healthcare Professionals Patients and/or Lay persons

The SSCP is NOT The SSCP is NOT

intended to replace the Instructions for Use (IFU) as the intended to give general advice on the treatment of a
main document to ensure the safe use of the device, nor is medical condition and/or to replace an implant card or
it intended to provide diagnostic or therapeutic the Instructions for Use (IFU).
suggestions to intended users or patients. It does not Readers must encouraged to contact their healthcare
replace the mandatory information on implant cards or in professional for questions about their medical condition
any other mandatory documents. or the use of the device.

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 Summary of Safety and
Clinical Performance
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Summary of Safety and Clinical Performance under EU-MDR

Physician Section
 The information included in a SSCP shall be fully aligned with the technical documentation (TD) of the device
including design verification/validation reports, risk management reports, Clinical Evaluation Report (CER), Post-
market Surveillance (PMS), Post-market Clinical Follow-up (PMCF) plans and reports
 When writing the CER of a device requiring a SCCP, keep in mind that the latter should outline numerical
comparative and normative data for risks, adverse events, etc.

 Although the content will be practically the same, watch out for
readability and language register in the section for patients or Lay persons

Patient/Lay Person Section

 This section must be written in a way that will be accessible to lay persons, i.e. it should be easily readable and
comprehended by people with a reading level of 12 years old and over.
 When preparing this section, do not assume that the reader has any formal medical education and/or prior
knowledge of medical terminology and clinical research principles
 Avoid abbreviations and acronyms that may confuse non-specialists, use short sentences and familiar
words
 If medical terms are used, be consistent: Start by giving a description of the lay term and put the
medical term in brackets.
 Always evaluate the readability of the text and mind the stylistic recommendations

“The SSCP shall be

objective and adequately
summarise both favourable
and unfavourable data”

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 Summary of Safety and
Clinical Performance
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SSCP contents for users/healthcare professionals

 Device Identification: trade name(s), manufacturer’s contact details and SRN, UDI identifier,
GMDN/EMDN codes, classification & respective rationale, year of first CE mark, contact details for
the Authorised Representative, identification of the validating Notified Body
 Labelling Statements: intended purpose, indication(s), intended population, contraindications,
warnings & cautions, intended lifetime, intended clinical benefit(s)
 Description of the device: models, accessories, configurations, design characteristics, operating
principles, device specifications including materials, expiry date, intended lifetime, packaging
specifications, whether the device is for single use or multiple uses and its method of sterilisation,
statements with respect to incorporation of medicinal substances, tissue(s) or cells of human or animal
origin, substances or combinations of substances that are absorbed by or locally dispersed in the
human body, materials containing and/or consisting of CMRs or endocrine-disrupting substances, or
materials that could result in sensitisation or an allergic reaction by the patient or user
 Description of accessories and/or devices or products that are used in combination with the
device
 Overview of risks associated with the use of the device: evaluation of clinical residual risks and
undesirable effects other than those included in labelling statements for contraindications, discussion
of risk severity, risk mitigation strategies and occurrence of hazardous situations, description of any
FSCAs, FSNs, CAPAs, recalls.
 Summary of Clinical Evaluation and PMCF: descriptive summary of ALL clinical data pertinent to
the device regardless of their origin, i.e data from clinical investigations prior and/or post CE-marking,
data related to equivalent devices, data from literature, PMS/PMCF activities (ongoing and/or
planned
 IN ALL CASES, a proper qualitative and quantitative identification must be provided (e.g.
study objectives, primary/secondary endpoints, eligibility, study population, summary of
results etc.
 Identification of the intended medical field: overview of alternative treatment options and
associated benefit-risk analysis
 Suggested profile and training needs for healthcare professionals
 Reference to Harmonised Standards and/or Applicable Common Specifications
 Revision History

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 Summary of Safety and
Clinical Performance
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SSCP contents for patients/lay persons

 Device Identification: trade name(s), manufacturer’s contact details, UDI identifier, year of first CE
mark and explanation of why this is an important information, contact details for the Authorised
Representative, identification of the validating Notified Body
 Intended use of the device:
 Intended Purpose: What is the device used for?
 Indications and Intended Patient Groups: When is the device used? (Indications) + Who is
the device meant for? (Intended Patient Groups)
 Contraindications: When should the device not be used?
 Description of the device: operating principles, design characteristics, models, accessories,
configurations, whether the device is for single use or multiple uses and whether it is supplied sterile,
statements with respect to incorporation of medicinal substances, tissue(s) or cells of human or
animal origin, substances or combinations of substances that are absorbed by or locally dispersed in
the human body, materials containing and/or consisting of CMRs or endocrine-disrupting
substances, or materials that could result in sensitisation or an allergic reaction by the patient or user
 Make sure you explain terms such carcinogenic, endocrine disruptor, sensitisation etc. as
well as the meaning of medicinal substance in a medical device
 Description of how the device works: how the device is powered, operated, maintained etc. This
section should include information/instructions on how the patient might use the device on its own.
 Risks and Warnings: an overview of risks associated with the use of the device, while ensuring that
the lay person understands quantification or risks as well as steps required to reduce these risks,
explanation or clinical residual risks and undesirable effects, outline of all warnings and precautions,
summary of any FSCAS and/or recalls explaining what they are and how they ensure the device's
continued safety
 Summary of Clinical Evaluation and PMCF: provide a description of available clinical evidence
preferably in a chronological order explaining how clinical data provides evidence of safety for the
device.
 Possible Alternative Options: describe the alternative therapeutic options available for the
intended purpose of the device and explain how these alternatives compare to the subject device
in terms of the risks and benefits
 Suggested Training for users: describe the experience, education and/or training of the intended
user including potential mandatory training required before using the device and any required
training for the continued safe use of the device

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