Ahead of the mandatory May 26, 2024 cutoff under Regulation (EU) 2023/607, medical device manufacturers must have an MDR-compliant Quality Management System (QMS) in place and a formal Notified Body application lodged to retain legacy market access.
May 26, 2024: The Decisive Gate for Legacy Medical Devices
Under the amended EU Medical Device Regulation transitional rules (Regulation (EU) 2023/607), May 26, 2024 stands as the legally binding cutoff date for manufacturers seeking to benefit from extended certificate validity through 2027 or 2028. By this date, manufacturers must have implemented an MDR-compliant Quality Management System under Article 10(9) and submitted a formal application for conformity assessment to a designated Notified Body, followed by a signed written agreement no later than September 26, 2024.
Auditing Translation Procedures Within an MDR Quality Management System
During Notified Body QMS audits, assessors closely examine how manufacturers control the translation of labeling, Instructions for Use (IFUs), and Field Safety Notices across EU Member States. Relying on unverified ad-hoc translations is a frequent source of major non-conformities. Partnering with an LSP certified under ISO 17100 and ISO 13485 provides documented traceability, translator qualification records, and certificate of accuracy trails required by Notified Body auditors.
Executive Takeaways for Global Enterprises
- Key Insight: May 26, 2024 is the mandatory deadline for lodging MDR Notified Body applications and establishing an MDR QMS.
- Key Insight: Signed written agreements with Notified Bodies must be completed by September 26, 2024 to maintain legacy CE market access.
- Key Insight: Documented ISO 17100 translation SOPs are essential evidence during Notified Body Quality Management System audits.
Nota Editorial y de Referencia: Este análisis técnico ha sido elaborado de forma independiente por el equipo de investigación de Alphatrad Worldwide con fines de análisis profesional y cumplimiento normativo. Para la documentación oficial y las fuentes primarias, consulte:
Fuente Oficial y Referencia: EUR-Lex - Official Journal of the European Union (Regulation EU 2017/745) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745)
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