Regulatory Knowledge At A Glance EU Basics Claims under the MDR and the IVDR (Art. 7/7) 10 January 2022 Conformity Assessment Options for Products Failing under the MDR 18 January 2021 Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements 7 January 2021 Trend Reporting under the MDR and IVDR (Art. 88/83) 12 November 2020 Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety under the MDR and the IVDR (Art. 95/90) 4 November 2020 Evaluation of Devices Suspected of Presenting an Unacceptable Risk or other Non-Compliance under the MDR and the IVDR (Art. 94/89) 4 November 2020 The Periodic Safety Update Report (PSUR) under the MDR and the IVDR (Art. 86/81) 30 October 2020 The Person Responsible for Regulatory Compliance (PRRC) under the MDR and the IVDR (Art. 15/15) 28 October 2020 The Field Safety Notices under the MDR and the IVDR (Art. 89(8)/84(8)) 19 October 2020 The Post-Market Surveillance (PMS) Plan under the MDR and the IVDR (Art. 84/79) 6 October 2020 The Certificate of Free Sale under the MDR and the IVDR (Art. 60/55) 15 September 2020 The EU Declaration of Conformity (DoC) under the MDR and the IVDR (Art. 19/17) 27 August 2020 The General Obligations of Manufacturers – Financial Coverage – under the MDR and the IVDR (Art. 10) 18 August 2020 The Clinical Evidences: Definitions and Elements under the IVDR 15 April 2020 Linguistic Requirements under the MDR and the IVDR 25 February 2020 EU’s Governmental Bodies 26 January 2020 Medical Device CE Marking 4 January 2020 MD vs IVD 3 January 2020 The Technical Documentation under the IVDR 3 January 2020 How to Complete the Essential Principles (EP) Checklist 2 January 2020 The New European Medical Device Regulation and In Vitro Diagnostic Device Regulation 1 January 2020 Process of Conformity and CE Marking: Key entities 1 January 2020 European Directives and Regulations 7 October 2019 7 Key Elements of a CE Technical File under the IVDR 6 February 2019 Democratizing MedTech Regulatory Knowledge #regulatoryandmore The Shop Share Facebook Twitter Linkedin Whatsapp Envelope 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 Follow Us Linkedin Twitter Facebook Instagram
Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements 7 January 2021
Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety under the MDR and the IVDR (Art. 95/90) 4 November 2020
Evaluation of Devices Suspected of Presenting an Unacceptable Risk or other Non-Compliance under the MDR and the IVDR (Art. 94/89) 4 November 2020
The Person Responsible for Regulatory Compliance (PRRC) under the MDR and the IVDR (Art. 15/15) 28 October 2020
The General Obligations of Manufacturers – Financial Coverage – under the MDR and the IVDR (Art. 10) 18 August 2020