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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

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 that 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:

A blog outlining how to create your own Quality Plan for compliance with the MDR
A blog explaining three major differences between the requirements of a Technical File for CE Marking and a 510(k) submission
An 8-part webinar-based course reviewing the requirements of Regulation (EU) 2017/745 and comparing the requirements with the MDD (93/42/EEC as modified by 2007/47/EC).
A new webinar teaching internal auditors and consultants how to perform a thorough audit of CE Marking Technical Files against the requirements of the new regulations.
We are also including a training webinar explaining the FDA’s UDI System, the native presentation slide deck, and we provide an exam (i.e., 10-question quiz) to verify training effectiveness. If you submit the completed exam to us by email in the native MS Word format, we will correct the exam and email you a training certificate with your corrected exam.

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