CE Marking Procedure (SYS-025)

This CE Marking procedure defines the requirements for technical documentation to comply with the new EU MDR (i.e. Regulation 2017/745).

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CE Marking CE Marking Procedure (SYS 025)

When this procedure was first created in 2012, it was specific to technical documentation requirements for the MDD (93/42/EEC as modified by 2007/47/EC). As of May 26, 2021, MedTech companies will need to comply with Regulation (EU) 2017/745 (the new EU MDR), and this procedure has been completely rewritten to comply with the new EU regulations. This procedure also meets the requirements for ISO 13485:2016, Clauses 4.1. and the following is a list of documents included:

  • SYS-025 A, Technical Documentation Procedure
  • FRM-049 A, General Safety and Performance Requirements (GSPR) Checklist
  • FRM-039 A, Declaration of Conformity Template
  • FRM-040 A, Technical File Index/Device Master Record Index Template

CE Marking CE Marking Procedure (SYS 025)
SYS-025 CE Marking Procedure/Forms
SYS-025 CE Marking Procedure / Forms
Price: $299.00

The CE Marking procedure listed above is compliant with the new MDR (Regulation 2017/745). The Declaration of Conformity Template and the GSPR Checklist have both been updated to the new regulations.  The new regulations for CE Marking of medical devices become effective on May 26, 2021. Until then, the MDD requirements will be applicable. If you need the previous versions of our CE Marking procedure and forms, please let us know.

Anyone who purchased an older version of this procedure from us is entitled to an updated version of the procedure and forms at no additional cost.

If your firm is preparing for compliance with the new MDR, you might also be interested in the following information provided on this website:

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