This CE Marking procedure defines the requirements for technical documentation to comply with the MDD (93/42/EEC as modified by 2007/47/EC).
This procedure is updated for ISO 13485:2016, and the following is a list of documents included:
- SYS-025 A, Technical Documentation Procedure
- FRM-038 A, Essential Requirements Checklist-(includes 6 General Requirements and 35+ Requirements Regarding Design and Construction)
- FRM-039 A, Declaration of Conformity Template
- FRM-040 A, Technical File Index/Device Master Record Index Template
All of the procedures and forms listed above our compliant with the MDR (93/42/EEC as modified by 2007/47/EC). The new regulations for CE Marking of medical devices, however, become effective on May 26, 2021. Therefore, we are updating all of our procedures and forms for compliance with Regulation (EU) 2017/745–including this CE Marking procedure and associated forms.
The Declaration of Conformity Template and the Essential Requirements Checklist have both been updated to the new regulations. We will be updating the other two documents in the month of August 2019. Anyone that purchased an older version of this procedure from us will be 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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