Oct 8, 2019

The European Commission has issued new guidance for manufacturers of implantable medical devices to develop Summaries of Safety and Clinical Performance (SSCP) based on Medical Devices Regulation (MDR) requirements.

MDCG Guidance 2019-9, Summary of safety and clinical performance; A guide for manufacturers and notified bodies, has been published. The document provides a clear rationale, including reference to articles and annexes, it helps in understanding most of the requirements and it provides a template for this document.

There has been criticism in the press and by medical professionals regarding getting a proper understanding of the risks and benefits of certain devices. The SSCP is intended to provide that extra understanding.

SSCP requirements laid out in Article 32 of the MDR

Article 32 of the MDR (EU) 2017/745 ) requires the creation of an SSCP for all implantable devices.

  • Rule 8 of Annex VIII places devices that are implantable in teeth in Class IIa.
  • Devices used in direct contact with the heart, the central circulatory system or the central nervous system are considered Class III.
  • Devices that have a biological effect or are wholly or mainly absorbed; devices that are intended to undergo chemical change in the body; intended to administer medicinal products; or are active implantable devices or their accessories are Class III.
  • Breast implants or surgical meshes; total or partial joint replacements (ancillary components exempted);  spinal disc replacement implants; or are implantable devices that come into contact with the spinal column (ancillary components exempted) fall under Class III.
  • All other implantable devices are in Class IIb.

SSCPs must be created for all these devices.

SSCP validation

The new MDCG guidance document is not only referring to article 32, it also refers to other articles and annexes, and even to other legislation and relevant documents.

Article 32.1 requires the SSCP to be validated by the Notified Body, where “validation” must be understood as verifying whether all relevant information in the technical documentation is reflected in the SSCP, and if all information in the SSCP is sourced from the technical documentation. If multiple devices are on the same certificate, they must be validated by the Notified Body at least once during the period of validity of the certificate. This means extra work for the Notified Body, and extra costs for the manufacturer.

After validation, or after a representative sample of multiple devices relying on the same certificate has been validated, the Notified Body must upload the SSCP in Eudamed. The Notified Body will validate against the data in the Technical Documentation.

Medical device SSCP readability considerations

The SSCP must be accessible to the intended readers. This means a clear layout and type face. It should preferably in read-only PDF, and searchable when using Adobe Reader or a similar application. It must also be written in English as well as the language(s) of the Member State(s) where the Device is made available. One part of an SSCP is for medical professionals and, in cases of implantable devices or devices that are used directly by patients, one part is for the intended patients.

These two parts should be clearly identified. The patient’s part must be written in such a way that the intended patient can understand that part of the SSCP. In case of a device intended for very young children,  it is obvious the SSCP must be written for the parents. In cases where the device is intended for children of 14 years of age or older, the SSCP should be written for these children to understand.

Between these two ages is a grey area where it would appear the SSCP should be written for both parents and children to understand. This age issue has been identified as a challenge in the field of medicinal products. A similar question can be identified for products intended for very old patients, where dementia may have an impact on how well patients understand this information. It appears the validation by the Notified Body does not cover the actual wording of the SSCP. The Notified Body will also not review translations.

Uploading SSCP data to Eudamed

After review, the Notified Body uploads the English translation into Eudamed as part of the initial review. If not all SSCPs were reviewed, the other reviews will be uploaded into Eudamed together with the certificate. SSCPs in other languages will be uploaded by the Notified Body within 15 days after they were received from the manufacturer.

Addressing residual risks

Extra challenges for the manufacturer can be expected regarding the requirement to address all residual risks and undesirable side effects. The wording in the MDR and the guidance document suggests this should cover all residual risks also mentioned in the IFU. Even after the most successful risk management, there will remain residual risks, although most will be very limited and unlikely to occur. In the part of the SSPC intended for patients and lay users, these residual risks should be explained in clear and easy to understand language. This may result in long chapters that obscure relevant residual risks in both IFU and SSCP documents.

If reference is made to an equivalent device, relevant details must be shared in the SSCP. If evidence is based on clinical investigations, such investigations need to be referenced as well. Any field safety corrective actions concerning the device should also be listed in the SSCP.

The MDCG guidance contains two annexes to help professional users as well as lay persons in drafting the SSCP, if such is appropriate. As mentioned above, there are some challenges for the whole industry in developing standards for the lay persons’ versions of the SSCP. But of course, this is provides a beginning of the goal of properly informing the user.

Learn more about European MDR compliance at Emergo by UL:

  • EU Medical Devices Regulation (MDR) preparation support and resource center
  • On-site MDR training for medical device manufacturers
  • Whitepaper: Understanding Europe’s MDR