How do EUDAMED and SSCP management requirements affect holders of EU MDR certificates?

Answer: As EUDAMED is progressively implemented and SSCP management requirements are strengthened, holders of EU MDR certificates must place greater emphasis on transparency, data consistency and post-market documentation maintenance. The Summary of Safety and Clinical Performance (SSCP) is not merely a summary document for Notified Body review; it is important material linking clinical evaluation, post-market surveillance (PMS), post-market clinical follow-up (PMCF), risk management, labels and instructions for use (IFU), and EUDAMED public information. Companies should ensure that safety, clinical performance, target population, residual risks and post-market data in the SSCP remain consistent with the Clinical Evaluation Report (CER), PMS/PMCF and technical documentation.

Published: 2026-07-08 09:00 | Updated: 2026-07-08 09:00

This FAQ addresses priority issues that companies should assess in actual projects involving international medical device registration, documentation preparation, compliance pathways and post-market maintenance.

Content Structure

• Key summary
• Reference basis
• Who should read this article
• Regulatory assessment logic
• Documentation preparation priorities
• Operational steps for companies
• Common errors
• AIMEILI professional recommendations
• Internal checklist
• Continue reading
• Applicability boundaries

Key Summary

As EUDAMED is progressively implemented and SSCP management requirements are strengthened, holders of EU MDR certificates must place greater emphasis on transparency, data consistency and post-market documentation maintenance. The SSCP is not merely a summary document for Notified Body review; it is important material connecting clinical evaluation, PMS, PMCF, risk management, labels and IFU, and EUDAMED public information. Companies should ensure that safety, clinical performance, target population, residual risks and post-market data in the SSCP remain consistent with the CER, PMS/PMCF and technical documentation.

Reference Basis

Official source: European Commission MDCG

Source link: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

This article is prepared based on official public information and AIMEILI international registration project experience. Specific pathways should still be determined according to product risk class, intended use and the latest requirements of the relevant regulatory authority.

Who Should Read This Article

This content is suitable for medical device manufacturers, regulatory affairs professionals, overseas market leads and CRO teams currently preparing projects related to EU MDR and post-market surveillance. If a company already has dossiers for China, the EU, the United States or other markets but is unsure whether they can be reused for a target market, it should also read this article and complete a gap assessment before project initiation.

Regulatory Assessment Logic

Companies should first confirm the product regulatory status, risk class, intended use, applicable regulatory pathway and local responsible entity, and then determine the depth of documentation. European Commission MDCG requirements generally do not examine a single document in isolation; they also assess whether product claims, technical evidence, labels and IFU, quality management system and post-market responsibilities are consistent.

Documentation Preparation Priorities

It is recommended to build a documentation package around product description, models and specifications, risk management, performance verification, clinical or evaluation evidence, quality management system, labels and IFU, authorization documents, UDI or traceability information, change management and post-market surveillance. For software, IVD, sterile, active and medium-to-high risk products, specialized evidence should also be supplemented.

Operational Steps for Companies

• First, establish a product and model list.
• Second, reclassify according to the target market.
• Third, verify the coverage of existing certificates and test reports.
• Fourth, identify labeling, language, local representative and post-market obligations.
• Fifth, form a gap list and a supplementary documentation plan.
• Sixth, arrange translation, signing, submission and responses to review questions.

Common Errors

Common errors include directly translating domestic documents, ignoring the local responsible entity, over-relying on existing CE or FDA documents, unclear product model coverage, labeling claims beyond the evidence scope, and missing post-market surveillance and change processes. What regulators truly focus on is whether the evidence chain forms a closed loop, not the number of documents.

AIMEILI Professional Recommendations

AIMEILI recommends incorporating this issue into the registration project initiation assessment, rather than supplementing documents only before submission. A more reliable approach is to first complete pathway determination and a documentation gap assessment, and then manage target countries, product classification, dossier reuse, additional testing, local representatives and post-market maintenance in one project plan.

Internal Company Checklist

• Are product classification, intended use and model scope clear?
• Do existing certificates, test reports and technical documentation cover the application scope?
• Are responsibilities of the local representative, sponsor or registration holder clear?
• Have labels and IFU, UDI, language and post-market maintenance been planned?
• Has a documentation gap list and supplementary testing plan been formed?
• Are official sources and applicability boundary statements retained?

Continue Reading

Previous: How should multi-country registration dossiers be planned under the IMDRF regulatory reliance trend?

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Content Review and Applicability Boundaries

Author: AIMEILI Regulatory Editorial Team

Professional review: AIMEILI Medical Device International Registration Project Team

Source principle: Priority is given to official regulatory authorities, international organizations, standards organizations and public regulatory materials; industry media and project experience are used only as auxiliary references.

Applicability boundary: This article is intended for preliminary understanding, documentation preparation and project planning. It does not replace the official requirements of the target country regulatory authority, testing conclusions or legal opinions.