The Essential EU MDR Acronym Glossary

Navigating the European Union Medical Device Regulation (MDR 2017/745) means mastering the alphabet soup of MDR acronyms. If you’re a medical device manufacturer navigating the EU MDR (Medical Device Regulation), you’re already aware that the regulation is packed with acronyms. These acronyms are crucial for compliance, but they can be challenging to decipher, especially when you need to translate documents that meet regulatory standards and MDR language requirements. Whether it’s Clinical Evaluation Reports (CERs) or your SSCP, accurate translations are essential for maintaining conformity across different languages within the EU.

This glossary highlights the most common and important acronyms of the MDR/IVDR and/or MedTech sector, so that you never get lost in this sea of abbreviations again!

What is CEP in medical devices? (Clinical Evaluation Plan)

The Clinical Evaluation Plan (CEP), as outlined in Part A of the EU MDR and Article 61, is vital for manufacturers to demonstrate the safety and performance of their devices. Accurate translation of the CEP ensures that all clinical evaluation methods, data collection processes, and benefit-risk assessments are clearly communicated in all languages. Without proper translation, critical details may be misinterpreted, leading to regulatory issues or delays. Regulatory bodies, Notified Bodies, and Competent Authorities across the EU may require the CEP in their official language to properly assess compliance.

What is CER in medical devices? (Clinical Evaluation Report)

The Clinical Evaluation Report (CER) is the final product of your clinical evaluation activities. It summarises and critically assesses clinical data to prove the device’s conformity with the General Safety and Performance Requirements (GSPRs).

„The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.” — Annex XIV, Part A, Section 4

What is PMS in medical devices? (Post-Market Surveillance)

The Post-Market Surveillance system (PMS) ensures that device performance is actively monitored after market entry. It helps identify risks and implement corrective actions. Manufacturers must document and update their PMS system, proportionate to the device's risk class (Article 83, Regulation (EU) 2017/745).

The PMS Plan outlines how data on device quality and safety is collected and analyzed. The PMS Report summarizes the findings, including any actions taken. Accurate translation of both documents is crucial for compliance and effective communication with regulatory bodies and stakeholders.is more than a regulatory checkbox—it's a core pillar of lifecycle safety. This system actively gathers data on device performance after market entry, enabling manufacturers to detect emerging risks early and implement timely actions.

“Manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device.” — Article 83(1), Regulation (EU) 2017/745

What is PMCF in medical devices? (Post-Market Clinical Follow-up)

Post-Market Clinical Follow-up (PMCF) is the clinical backbone of your PMS system. It collects real-world clinical data after market entry to confirm that safety and performance claims remain valid over time. As the MDR states, “PMCF shall be understood as a continuous process that updates the clinical evaluation” (Annex XIV, Part B).

Because PMCF plans and reports are reviewed by Notified Bodies and authorities in different countries, accurate translation is essential to ensure consistent interpretation of clinical outcomes, risks, and conclusions across markets.

What is PSUR in medical devices? (Periodic Safety Update Report)

The Periodic Safety Update Report (PSUR) consolidates the findings of PMS and PMCF into one structured overview. It’s required for Class IIa, IIb, and III devices and submitted periodically and is checked by NBs and CAs. It’s not a plan or a system, but a snapshot in time that shows regulators how your device behaves in the real world.
Under the MDR, “manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report” (Article 86).

In practice, a PSUR often circulates across borders—meaning every word must tell the same story in every language.

What is SSCP in medical devices? (Summary of Safety and Clinical Performance)

The Summary of Safety and Clinical Performance (SSCP) is the EU MDR’s way of putting clinical evidence on display. For implantable and class III devices, this public document distils safety, performance and benefit–risk data into a clear summary for healthcare professionals—and, when relevant, patients—via EUDAMED. Because it is meant to be read across Europe, translation is a legal requirement, not a courtesy. As MDCG 2019-9 Rev.1 states, “the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold”. One device, one clinical message—no matter the language.

What is CAPA in medical devices? (Corrective and Preventive Actions)

Corrective And Preventive Action (CAPA) is where regulators stop reading politely and start reading word by word. It documents how non-conformities are corrected, why they happened, and how recurrence is prevented—across the entire QMS. Under MDCG 2024-12, CAPAs must restate non-compliances “without modification, including the official DG SANTE translation”. In other words: no rewording, no creative edits, no shortcuts. When CAPAs circulate between notified bodies, authorities, and joint assessment teams, translation becomes a compliance control, not an afterthought. One mistranslated sentence can keep a finding open.

What is FSN in medical devices? (Field Safety Notice)

A Field Safety Notice (FSN) is the manufacturer’s urgent message to the field when something needs to change—now. It explains risks, corrective actions, and what users must do to stay safe. Under the MDR, language is non-negotiable: “The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken” (Article 89(8)). In practice, FSNs must be clear, immediate, and perfectly translated—because in a safety alert, every word counts. If in doubt, check out the Q&A to fill out the FSN, published by the European Commission.

What is FSCA in medical devices? (Field Safety Corrective Action)

A Field Safety Corrective Action (FSCA) is the real-world fix to a serious safety problem—recalling devices, updating software, changing labels, or retraining users. Unlike the FSN (the message), the FSCA is the action itself, and it must be reported to authorities without delay. As the MDR states, manufacturers must report “any field safety corrective action in respect of devices made available on the Union market” (Article 87(1)(b)).

Because FSCAs are implemented under tight timelines and across borders, clear, unambiguous translation is critical—so every authority, distributor, and user understands exactly what must be done, and when.

Conclusion

EU MDR acronyms are more than regulatory shorthand—they point to documents that must withstand scrutiny across countries, authorities and languages. CEPs, CERs, PMS and PMCF reports, PSURs, SSCPs, CAPAs, FSNs and FSCAs are reviewed by Notified Bodies, Competent Authorities, joint assessment teams, healthcare professionals and sometimes patients, often in parallel across multiple Member States. In this environment, translation is not an afterthought; it is part of regulatory control itself.

For this reason, working with a certified translation company specialised in medical device translation is strongly recommended—one that understands not just the terminology, but the regulatory relevance behind each acronym.