MDR and IVDR Critical Update:

BSI has submitted designation applications for the Medical Devices Regulation (Regulation (EU) 2017/745) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746) to both the UK and The Netherlands Competent Authorities. 26 November 2017 was the first day that Notified Bodies were allowed to apply for designation under the MDR and IVDR, BSI were among the first wave of Notified Bodies to submit for both Regulations. The next step is for the Designating Authority, MHRA in the UK and IGJ in The Netherlands, to review our application and write a preliminary report to be sent to the Commission so that they can schedule Joint Assessment audits of BSI.

BSI is proud to work towards designation for these critical Regulations and will continue to strive for excellence in our Notified Body activities over the transition period. We will ensure that you are kept up to date with the progression going forward.

New Medical Devices Regulation and IVD Regulation now published

The final text of the new European Medical Devices Regulation (MDR) has been published in the Official Journal of the European Union. The Regulations will enter into force on May 25th, marking the start of the transition period for manufacturers selling medical devices into Europe.

The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.

See the latest information from the EU Commission here

The start of this long process of change occurred on 26 September 2012, when the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives.

The original proposal documents can be found via the following pages.

MDD-IVDD communication 2012-540
IVDD Regulation proposal 2012-541
MDD Regulation proposal 2012-542

The final EU Commission text can be found here

Read the final text

When are the Medical Device Directives changing?

Following entry into force on May 25^th, manufacturers have three years to transition to the new Medical Device Regulation. The new rules will apply from May 2020 for medical devices.

Use our Frequently Asked Questions document to learn more about the transition and the changes to the requirements.

Further details of transition can be heard in the MDR webinar.

Download the FAQ

Informative BSI white papers

NEW! MDR Safety and Performance Requirements white paper

The Safety and Performance Requirements (SPRs) of the Medical Devices Regulation (MDR) replace the previous Directives' Essential Requirements (ERs) and outline the key areas to address within the Technical Documentation. Our new complimentary white paper provides comparison of the SPRs and ERs, allowing you to understand what's changing in more detail.

Download your copy today.

The European Medical Devices Regulations - What are the requirements for 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; the PMS system, which is the comprehensive process used to collect, analyze and take action on PMS information; the PMS plan, which describes the application of the PMS system to a device or device family;preparation of a summary report of PMS information; complaint handling and reporting of vigilance; and, electronic submission of vigilance data and summary reports of PMS.

Learn more about the new requirements, download your copy today.

Planning for implementation of the European Union Medical Device Regulations - Are you prepared?

This white paper examines the practical aspects of implementation of the new Medical Devices and In Vitro Diagnostics Regulations. It explores the decisions you face, so you can understand your organization's preparedness, and begin to plan your transition.

Download your copy today.

How to prepare for and implement the upcoming MDR - Dos and Don'ts

The white paper discusses the requirements of the MDR in more detail and sets out a checklist of likely actions that manufacturers of medical devices will have to take in order to comply with the Regulation. These actions are set alongside the corresponding chapter of the Regulation and include an indication of when action is required – before, during and after the transition period of the MDR.

To understand more about the impacts of the Regulation on your business, download your copy today.

The proposed EU regulations for medical and in vitro diagnostic devices

An overview of the likely outcomes and the consequences for the market, updated October 2015.

Whitepaper-updated-proposed-EU-regulations

To understand how the changes will impact the industry, and what this means for your business, download your complimentary copy of BSI's updated whitepaper. Authored by Dr Gert Bos, Head of Regulatory and Clinical Affairs at BSI, and Erik Vollebregt, Partner at Axon Lawyers, the white paper provides insight into the Regulation's consequences for the market. Don't delay in understanding the consequences of these significant, mandatory changes on your business. Download your copy today

Informative BSI white papers

Register for our webinars and prepare for the changes

Listen back to recent webinars:

The role of the Person Responsible for Regulatory Compliance under the future Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

This webinar will discuss the concept of the Person Responsible for Regulatory Compliance as described in the current draft version of the Medical Device Regulation and the IVD Regulation, provide a brief background on the Pharma Qualified Person duties and how this concept is translated into the Medical Device and IVD world, and will cover some of the practical aspects of the implementation of this new requirement for manufacturers.

Listen back to recent webinars:

New version of MEDDEV 2.7.1 Revision 4: Key changes and clarification

Medical Device Regulation - Implications on manufacturers resources

Update: Proposed European Union Medical Device Regulations

Will your product be reclassified under the new MDR?

Where can I find further information?

This transition page will be updated regularly with the latest facts. BSI will run a series of webinars and white papers to ensure we share valuable information with you regarding these significant changes.

The official non-BSI websites can also provide additional background and detailed information:

European Commission

Competent authority, MHRA

If you have questions regarding the changes please contact your BSI Scheme Manager for initial questions.