EC Declaration of Conformity
Manufacturer
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Medical Device
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Classification
Medical Device Class: \
Classification determined in accordance with \
Reference Art. 51 MDR, Section 1, to identify the applicable classification rule. These are detailed in Annex VIII of the MDR.
For instance, software providing information to assist in diagnostic or therapeutic decisions or software monitoring physiological processes is classified as Class IIa under Rule 11 of the Annex.
Conformity Assessment
Conformity assessment procedure: \
Refer to Art. 52 MDR, Section 2, for details on conformity assessment procedures for your medical device class. Procedures are outlined in Annexes IX to XI of the MDR:
- Class III devices (excluding custom-made or investigational devices): Annex IX, or Annex X in combination with Annex XI.
- Class IIb devices (excluding custom-made or investigational devices): Annex IX, Chapters I and III, including TechDoc assessment per Para. 4 for at least one representative device of the generic device group. For Class IIb implantable devices, Annex IX applies to all devices. Alternatively, manufacturers can opt for type examination under Annex X with Annex XI.
- Class IIa devices (excluding custom-made or investigational devices): Annex IX, Chapters I and III, including TechDoc assessment per Para. 4 for at least one representative device in each category.
- Class I devices (excluding custom-made or investigational devices): Develop technical documentation as specified in Annexes II and III.
- Class I devices in sterile condition, with a measuring function, or as reusable surgical instruments: Follow Chapters I and III of Annex IX or Part A of Annex XI.
The above-referenced Medical Device complies with the provisions of Regulation (EU) 2017/745 on medical devices.
Note #1: This document must be signed. Use an electronic signature if supported by your software. Otherwise, print, sign manually, scan, and save to your QMS folder.
Note #2: Review Annex IV of the MDR to ensure all necessary details are included. For instance, if applicable, add product/trade names and Notified Body details.
Location, Date, CEO’s Signature
Location, Date, PRRC’s Signature