This interactive document allows you to detail how you intend to meet the additional requirements of the new Regulation, and should be used in conjunction with Regulation (EU) 2017/745. While not intended to be an exhaustive checklist, it contains summary statements of the significant MDR changes from previous regulations. Questions are grouped by key theme, including:
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The new Medical Device and In-Vitro Diagnostic Regulations have been adopted. Within the new Regulations, articles 10-15 outline the roles and responsibilities of the various actors involved in the manufacture and supply of products into Europe.
In 2016, there was a new version of ISO 13485, and in 2017 there was MDR and IVDR. The many changes require robust, efficient plans to ensure that all new requirements are met within the relevant transition periods.
The webinar outlines the new MDR requirements so that medical device manufacturers can effeciently deploy their resources to ensure uninterrupted CE Marking and EU market access during and after the transitional period of the new Medical Device Regulation.
This webinar will discuss the implications of the new MDR on manufacturer's resources, and highlight some key points of note for manufacturers as they plan for the transition.
This webinar will explore the new requirements of the recently released (and more MDR compliant) Revision 4 of the MEDDEV 2.7.1, specifically its guidance on conducting a clinical evaluation.
The new Medical Device Regulation contains enhanced requirements for PMS plans, including conducting active post-market clinical follow-up (PMCF) when necessary, preparing periodic safety update reports (PSUR) for Class II and Class III devices with external review.
The purpose of this white paper is to compare the ERs in the MDD and AIMDD to the SPRs in Annex I of the new MDR. Where there are 13 ERs in the MDD and 16 in the AIMDD, there are 23 SPRs in the new MDR.
BSI has created a guide to help you to map the MDR Safety and Performance Requirements (SPRs) to the Essential Requirements of the Medical Devices Directive (MDD), and the Active Implantable Medical Devices Directive (AIMDD).
This FAQ document provides answers on the new EU MDR and IVDR, and their anticipated impact on manufacturer resources.
This paper focuses on the practical aspects of implementation and highlights some of the major changes. It discusses decisions that need to be made by affected organizations and includes questions to ask about your organization’s preparedness in order to comply with the new requirements.
This paper provides detailed information to help manufacturers of medical devices understand the actions that are envisaged before, during and after the transitional period of the EU Medical Devices Regulation MDR.
This paper addresses a number of areas, including PMS as an element of the management of clinical evidence throughout the device lifecycle including the PMS system, which is the comprehensive process used to collect, analyze and take action on PMS information, the PMS plan and much more.
From May 2017adoption until mandatory transition, there are approximately 36 months for the new EU Medical Device Directive, and 60 months for the In Vitro Diagnostic Directive.
Dates are based on BSI's current understanding of the process/steps to be completed.