Basics | EU, Regulatory Basics by Regulatory & More Jan 18, 2021 Conformity Assessment Options for Products Failing under the MDR Overview Purpose (+) Scope The conformity assessment route for CE marking varies according to the assigned class of device as describes in MDR Article 52 and in the MDR Annex IX, Annex X and Annex XI depending on the device class, manufacturers have some choice regarding the conformity assessment route. Conformity Assessment Options Class I Annex II and Annex III Class I (special): With measuring function, sterile, or reusable Annex II, Annex III and Annex IX, or Annex XI Part A Class IIa Annex II, Annex III and Annex IX of each category of devices or Annex X coupled with Annex XI Part A or Annex XI Part B Class IIb Annex II, Annex III and Annex IX, of each generic category of devices or Annex X coupled with Annex XI Part A or Annex XI Part B Class IIb (special): Implantable devices Paragraph Class III Annex II, Annex III and Annex IXorAnnex X coupled with Annex XI Part A or Annex XI Part B Custom-made Devices (a) Not implantable: Annex XIII(b) Implantable Class III: Additionally Annex IX or Annex XI Part A Mentionned Annexes Annex II – Technical documentation Annex III – Technical documentation on post-market surveillanceAnnex IX – Conformity assessment based on a quality management system and assessment of the technical documentationAnnex X – Conformity assessment based on type examinationAnnex XI – Conformity assessment based on product conformity verification – Part A: Production Quality Assurance Annex XI – Conformity assessment based on product conformity verification – Part B: Product VerificationAnnex XIII – Procedure for Custom-Made Devices References Regulation (EU) 2017/745 MDR: 02017R0745 — EN — 24.04.2020 — 001.001 (consolidated version) Share on facebook Share on twitter Share on linkedin Share on whatsapp Share on email Best Sellers View cart “Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0)” has been added to your cart. Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0) $50.00 Add to cart Checklist – ISO 13485 2016 Internal Audit (v.1.0) $50.00 Add to cart Template – SOP Master Validation Test Plan (v.1.0) $50.00 Add to cart Template – Technical Documentation Table of Content according to the IVDR (v1.0) $50.00 Add to cart Template – SOP Technical Documentation according the IVDR (v1.0) $50.00 Add to cart Related Posts Project Management How to Create a Project Timeline in Simple Steps Read More » 17 June 2022 Visual Maker How to create a Project Timeline with VisualMaker? Read More » 4 June 2022 Basics | U.S. The IVD Product Types: RUO, IUO, GPR, ASR Read More » 31 January 2022 Basics | EU Claims under the MDR and the IVDR (Art. 7/7) Read More » 10 January 2022 Basics | U.S. The Investigational Device Exemption (IDE) Read More » 28 January 2021 Basics | EU Conformity Assessment Options for Products Failing under the MDR Read More » 18 January 2021 Follow Us Linkedin Facebook Twitter Instagram #regulatoryandmore EuropeMDMDRMedical Devices
Basics | EU Conformity Assessment Options for Products Failing under the MDR Read More » 18 January 2021