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Technical Documentation and Medical Device Regulation

Technical Documentation and Medical Device RegulationA Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation 2017/745Dr Julianne Bobela, Project Associate; Dr Benjamin Frisch, Senior Associate; Kim Rochat, Senior Partner; and Michael Maier, Senior Partner; all at Medidee Services SAiiTechnical Documentation and Medical Device RegulationContentsIntroduction 1 Transition to the new legislation 1 Compiling the Technical Documentation 2 Content of the Technical Documentation 4 Other Technical Documentation requirements 5 Post-market surveillance plan 6 Conformity assessment review of Technical Documentation 7 Person responsible for regulatory compliance 8 Requirements related to authorized representatives

the device to the NB for pre-market or post-market conformity assessment activities. With the aim of globally standardizing medical device regulatory submissions, the Global Harmonization Task Force (GHTF) has created the ‘Summary Technical Documentation (STED)’, intended to be a consistent, summarized or abridged form of the

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Comparison of the articles of the European Medical Devices ...

www.medical-device-regulation.eu

pages. This table presents a summary of the provisions of some of the articles of the MDD and MDR together with commentary providing discussion and highlighting the key differences. The table is an excerpt from the MDR/IVDR Smart Support available in Compliance Navigator. Topic Scope - inclusions Medical Devices Directive (93/42/EEC), as amended

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MedDev 2.7.1 Rev 4 Medical Devices Regulation Clinical ...

www.medical-device-regulation.eu

Clinical Evidence –MedDev 2.7.1 & MDR Clinical Evidence Clinical Evaluation Clinical Data •the clinical data and clinical evaluation report pertaining to a device •sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s) when used as intended by the manufacturer

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MDR Labelling Requirements - Medical Device Regulation

www.medical-device-regulation.eu

•Sterile package requirements (23.3) • AIMDD already distinguishes sterile pack from trade pack / sales pack; this distinction is new to MDD devices • Mostly a sub-set of existing labelling requirements •“an indication permitting the sterile packaging to be recognized as such,”–i.e. disclaimers, sterile symbol,

  Devices, Medical, Sterile, Packages, Medical device, Sterile package

Post-market surveillance - Medical Device Regulation

www.medical-device-regulation.eu

Describes means of tracing and identifying devices References the documented procedures for the – Summarizes the results and conclusions of analysis of the PMS data Includes rationale for, and description of, any preventive action or corrective actions taken Updated when necessary and made available to the competent authority upon request

  Analysis, Surveillance, Post, Market, Tracing, Post market surveillance

Medical Device White Paper Series Sterilization ...

www.medical-device-regulation.eu

New emphasis on cleaning, disinfection and sterilization of reusable devices. Table 1 – Comparison of the requirements in relation to Infection and microbial contamination in the Medical Devices Regulation and the Medical Devices Directive 1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,

  Devices, Medical, Cleaning, Medical device, Sterilization, Reusable, And sterilization of reusable devices

Medical Device White Paper Series Risk management for ...

www.medical-device-regulation.eu

the need to develop an international standard for risk management of medical devices and established their Joint Working Group 1. EN 1441 [15] was taken as a starting point and was converted with minimal editing to BS EN ISO 14971-1 [16] in 1998, which thus also covered risk analysis. BS EN ISO 14971-1 was intended to be

  Devices, Management, Medical, Management of medical devices

Medical Device White Paper Series Medical device clinical ...

www.medical-device-regulation.eu

MEDDEV 2.7/3 Rev. 3 on serious adverse event (SAE) reporting New requirements under the MDR The MDR introduces new requirements, which need to be carefully reviewed and addressed in applicable procedures for the conduct of clinical investigations under the MDR. The new MDR requirements presented

  Events, Serious, Adverse, Serious adverse events

REGULATION (EU) 2017/ 745 OF THE EUROPEAN …

www.medical-device-regulation.eu

5.5.2017 EN Official Jour nal of the European Union L 117/3 (1) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121). (2 (((

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www.pharmout.net

The Good Manufacturing Practice regulations that govern pharmaceutical and medical device manufacturing can seem overwhelming. Use these ten golden rules to drive your day-to-day operations, keeping them in mind whenever you make decisions that have GMP implications. This white paper is an ideal refresher for the experienced

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MedTech Europe guidance for assigning Basic UDI-DI

www.medtecheurope.org

sets to provide in EUDAMED and IVDR UDI and device data sets to provide in EUDAMED): 4 MDCG 2018-1 v3: This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of

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