Regulatory References ISO 13485:2016 4.2.3 ISO 20417:2021 All User Manual [Insert Product Name] Version: [Insert Content] Date: [Insert Content] [Placeholder for Company Address] Email: [Insert Content] Website: [Insert Content] [Placeholder CE Sign] [Placeholder UDI] [Insert Product Name] is a Class […]
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Mapping of Requirements to Document Sections MDR Class MDR Section Document Section (All) Annex II, 1.1 a) – d), h), i) (All) ISO 14971:2019 Section Document Section 5.2 (All) IEC 62366-1:2015 Section Document Section 5.1 (All) Product Information Name: \
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Requirement Mapping Medical Device Regulation (MDR) Document Section Annex VIII (All) Associated Documents: Intended Use SOP Product Certification and Registration Overview Product: (Enter content) Version: (Enter content) Classification: (Enter content) Rule: (Enter content) Justification for classifying the product as a
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EC Declaration of Conformity Manufacturer \ \ Medical Device \ \ \ 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
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Essential Requirements MDD (93/42/EEC) This document addresses all essential requirements outlined in Annex I of the MDD. Unlike other templates, the quoted sections below directly reference the MDD, without added explanations. These excerpts represent legal text from the MDD itself,
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