Navigating the New MDR SSCP & IVDR SSP Requirements

Among the many new requirements of MDR is the need to supply a Summary of Safety and Clinical Performance (SSCP) for implantable devices and Class III devices, other than custom-made or investigational devices.

IVDR has added a similar documentation requirement called a Summary of Safety and Performance (SSP) for Class C and D in-vitro devices, other than devices for performance studies.

MDR SSCP

The MDR SSCP is new to the medical device industry with a structure that may need to include information similar to the lay summary used in clinical trials for investigational medicinal products and treatments. The document is intended to include exhaustive detail on the medical device that is comprehensible to healthcare professionals and, when relevant, to patients with no medical background, and must be validated by a Notified Body.

The regulation indicates that patients should be part of the target audience for SSCP information for any implantable devices for which patients receive implant cards and for any Class III devices intended for direct use by the patient.

In these instances, a separate SSCP section should be included that is specifically intended for patients, omitting any performance claims or “promotional language” that may mislead patients. In this section, medical terminology and industry acronyms should be kept to a minimum and only used with a plain language explanation preceding the technical terms.

Referencing MDR Article 32, the MDCG advises that device technical documentation such as the Clinical Evaluation Report (CER), Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF) should be the primary sources for information included in the SSCP. The IFU may also be used as an SSCP information source if deemed appropriate.

According to MDR Article 32, the following elements should appear in the SSCP at a minimum:

• Device identification and manufacturer, including Basic UDI-DI and SRN, if available.
• Device intended purpose with indications, contraindications, and target populations.
• Device description including previous generations or variants, if they exist. Other devices, accessories, or products intended for use in combination with the device.
• Possible diagnostic or therapeutic alternatives.
• Reference to any harmonized standards and Common Specification (CS) applied.
• Summary of the clinical evaluation as referenced in Annex XIV and relevant information on post-market clinical follow-up (PMCF).
• Any residual risks and undesirable effects, warnings, or precautions.
• Suggested profile and training for users.

IVDR SSP

IVDR Article 29 details information to be included in the SSP:

• Intended use of the device
• Device description
• Reference to any harmonized standards and Common Specification (CS) applied
• Risks and warnings
• Summary of performance evaluation and post-market performance follow-up (PMPF)
• Metrological traceability of assigned values
• Suggested profile and training for users

Supporting data from technical documentation such as the IFU, Performance Evaluation Report (PER), and Periodic Safety Update Report (PSUR) should be used, and the SSP must also be validated by a Notified Body.

If required, a separate SSP section should be included, specifically intended for patients and written in terms a lay person would understand. Medical terminology and industry acronyms should be kept to a minimum and only used with a plain language explanation preceding the technical terms.

Common Requirements

Both SSCPs and SSPs are required to be reviewed annually and kept updated and available in the EUDAMED system with revision history.

The SSCP and SSP should be provided in English and translated into languages accepted in the EU Member States where the device is intended to be sold. The documents should include a statement as to which language was used for validation by the Notified Body.

The new regulations emphasize the intelligibility of provided information for the intended audience, whether medical professional or patient, and places responsibility for its accuracy on the manufacturer.

MDR Article 18 states “The information {..} shall be provided {…} to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate.”

IVDR Article 10 states, “The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing shall be easily understandable and provided in the official Union language(s) determined by the Member State in which the device is made available to the user or patient.”

The Medical Device Coordination Group provides further guidance in MDCG 2019:

“In order to meet the requirement in the MDR that the SSCP shall be written in a way that is clear to the intended user and, if relevant, to the patient, the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold. {…} Note that Member States may have different language requirements for an IFU depending on whether the information is intended for health care professionals or for patients. The SSCP part intended for patients should be provided in all the languages required for IFUs intended for patients in the Member States concerned.

There should be one SSCP document for each language. The manufacturer should ensure, through their quality management system, that the translations are correct.”

Compliance Strategy

Complying with the new MDR or IVDR documentation may require high cost and effort for manufacturers, depending on the number of devices meeting the SSCP/SSP criteria.

Here are some strategies that should help mitigate unexpected resource burdens. The good news is that implementation will also smooth the way for future compliance challenges – there is always a new regulation – and open the door to more efficient content creation and translation workflows overall.

Product Gap Assessment

1. Conduct a Product Gap Assessment from a Regulatory perspective. It is imperative to know which of your products are affected. Will any change in classification? How many will require a “patient section” added to the SSCP or SSP for healthcare professionals? Will any prove to be unworthy of the effort and expense to reclassify from a market share or revenue perspective?
2. Once you have the list of affected products, what are the revenue implications for each? Should you prioritize by existing sales? By potential value of new markets or regions?
3. What are the regulatory or legal implications by region? What represents the biggest potential for loss or fines, or for stop shipment?

Terminology Management

Standardized terminology and terminology management will be more critical than ever, as two sets may be required – one for healthcare professionals and another for patients. Keeping these segregated through proper tagging and ensuring the correct set is applied should minimize rework and allow for content reuse in all applicable languages.

Controlled Content and Authoring

Utilize the templates supplied by the Medical Device Coordination Group and the adoption of a content management system that allows for source content reuse should prove quite helpful in generating these new documents.

Process Automation

Identify processes that can be expedited through software-driven handoffs, artificial intelligence, and other automation, leaving room for humans to do what they do best with content and data – create, edit and assess.

If possible, this would be the time to integrate ERP, PLM, and QMS for seamless information exchange to manage the sheer volume of annual updates to SSCP or SSP documents.

Translation Memory Cleansing

Once standardized terminology is established, it is advisable to undertake translation memory cleansing to ferret out incorrect terminology for healthcare professionals and patients. Artificial Intelligence can greatly reduce cost, time, and effort to accomplish the cleansing and will pay great dividends in avoiding rework as well.

Establish A Context Vector

AI can be used to even greater effect by inspecting inbound translation kits by verifying against a Context Vector TM – analogous to a validated “golden TM” – and sending any potential errors to a human post-editor for disposition.

Machine Translation

Many types of Life Science content are highly repetitive and technical, making it particularly well-suited for MT. Paired with a human editor and artificial intelligence as a “gatekeeper” to flag errors, this is proving to be the path forward.

Structuring source material with MT in mind will help expedite the recreation of similar content types. Identify “boilerplate” content as well as segments of the SSCP or SSP that can repeat except for variable text specific to the product(s) being documented. This will allow any required reviews to be focused on content segments unique and most critical to the product’s functioning and safety.

A validated terminology database in tandem with a translation memory that is optimized for edit distance (Context Vector) can often supply equivalent quality results to current translation methods, especially as part of a process incorporating a custom machine translation engine and human post edit, with AI-supported language quality assurance as the final stage.

While the perceived “fluency” may still require human post edit, advances in neural MT encoding and decoding can now provide translation accuracy in the high 90^th percentile, which rivals or exceeds more traditional TM-based fuzzy matching in accuracy.

Currently, this approach can save an average of 20-40% in post-edit effort without increasing risk.

Summary

Compliance with the new MDR / IVDR requirements can be complex and resource intensive. Updating processes or implementing new solutions will allow for a smoother flow of information as the volume of documents continues to increase over time.

Reference:

MDCG 2019-9: Summary of safety and clinical performance. A guide for manufacturers and notified bodies

MDCG 2022-9: Summary of safety and performance Template

MDR – Regulation [EU] 2017/745

IVDR – Regulation [EU] 2017/746

EUDAMED