Start with the BSI MDR Readiness Review.

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:

  • Scope and Classification (Article 51 & Annex VIII)
  • Routes of Conformity (Article 52)
  • Impact of the MDR on Quality Management Systems (QMS)
  • Safety and Performance Requirements (SPR)
  • Clinical Evidence
  • Other new Requirements

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Working with the updated Medical Device and In Vitro Diagnostic Regulation? These live and on-demand webinars help you understand how the changes will affect your compliance process.

Roles and responsibilities in the new EU Medical Device and IVD Regulations

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.

ISO 13485:2016, the Medical Device Regulation and the IVD Regulation - Are they aligned?

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.

European Union Medical Device Regulations Detailed

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.

Medical Device Regulation - Implications on Manufacturers Resources

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.

New version of MEDDEV 2.7.1 Revision 4: Aligning with MDR

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.

Post Market Surveillance and Vigilance - do you know the requirements?

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 new Medical Device and In Vitro Diagnostic Regulations bring more quality/risk control throughout the life-cycle and supply chain. The following resources help explain the key areas of both compliance and flexibility when applying the regulations.

General Safety and Performance Requirements (Annex I) in the New Medical Device Regulation.

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 MDR Safety and Performance Requirements (SPRs) Mapping Guide

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).

The key questions we've been getting about the impending MDR/IVDR transition - and their answers

This FAQ document provides answers on the new EU MDR and IVDR, and their anticipated impact on manufacturer resources.

Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?

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.

The upcoming European Medical Device Regulation– Do's and Don’ts

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.

What are the requirements for EU MDR vigilance reporting and post-market surveillance?

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.

How much time is left before you must transition to the EU Medical and In Vitro Device Regulations? And what are the directives' requirements?

Read the final Regulation (EU) 2017/745 (MDR) text here
Read the final Regulation (EU) 2017/746 (IVDR) text here

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.

Begin your MDR/IVDR transition planning now . Just fill out the top of page form to download immediately. If you have specific questions about complying with the new regulation's requirements, use the form below to contact BSI directly.

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Find out how MDR/IVDR transition support could benefit your business.

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