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New Medical Devices 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 Regulation entered 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?

The Regulation entered into force on May 25th, giving manufacturers 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.

Download your FAQ

Informative BSI white papers

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

BSI webinar programme will enable you to prepare for changes:

Listen back to our informative webinars

Roles and responsibilities in the Medical Device and IVD Regulations

The new Medical Device and In-Vitro Diagnostic Regulations are expected to be adopted in the first half of 2017. 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.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will outline the actions required, for each of the roles outlined in the new Regulations.

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

The new Medical Device Regulation is expected to be adopted in the first half of 2017. The Regulation contains significant changes in requirements in the post-market area, including PMS planning and implementation, vigilance reporting and handling field safety corrective actions.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will allow you to start planning how to meet the new requirements in this area.

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

The new Medical Device and In Vitro Diagnostic Regulations will be published in the coming months. One of the novelties introduced as part of this major regulatory change in Europe is the concept of the Person Responsible for Regulatory Compliance. This was inspired by the pharmaceutical “Qualified Person” role and has been dramatically reviewed and diluted down since the original draft regulation proposal. However, the basic principles remain.

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.

The In Vitro Diagnostic Regulation - Changes to the IVD regulatory landscape

The upcoming changes to the regulatory requirements for IVDs will require a thorough understanding from manufacturers to ensure a smooth transition from the IVD Directive to the IVD Regulation. Robust and timely plans should be made, and to do so, manufacturers need to be aware of the magnitude of changes and the activity that lies ahead.

This webinar discussed the key requirements that IVD manufacturers will need to be aware of, highlighting the areas that are most changed vs. the current IVD Directive. There is an explanation of the current position and expected timelines, and acknowledgement of the role of the Notified Body, with emphasis on the next steps for manufacturers.

The new revision of MEDDEV 2.7.1 Revision 4: Key changes and clarifications

Revision 4 of the MEDDEV guidance document 2.7.1 - Clinical Evaluation: A guide for manufacturers and notified bodies under Directive 93/42/EEC and 90/385/EEC - was released by the European Commission on 1st July 2016. This document provides information to manufacturers on conducting a clinical evaluation, including demonstration of scientific validity of your data and conclusions.

This webinar will explore the key changes in the new Revision, discussing the new requirements and noting the main clarifications within the guidance document. It will highlight the areas for you to be aware of and consider when conducting clinical evaluations.

Medical Device Regulation: Impact on manufacturer resources

The impact of the upcoming regulatory changes for manufacturers must be clearly understood, and robust, timely plans should be put in place to ensure a smooth transition over the next three years. The change will impact not only Quality and Regulatory functions, but also Operations, Marketing, and Strategic Planning. Manufacturers are encouraged to understand the changes and the impact on their business, to ensure they are fully prepared to begin their transition as soon as possible, minimising the possibility of delays in getting certified under the new Regulation.

This webinar discussed 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 to the new Regulation.

Update on the EU MDR

What will companies need to be aware of, and when will changes impact them? All medical device manufacturers must plan and prepare for the new Regulation because EU law does not allow grandfathering of devices, so every device manufacturers make must comply with the new requirements aligned with the transition time frames proposed.

This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar outlines the new requirements so that medical device manufacturers can start planning their resources to ensure uninterrupted CE Marking and EU market access during and after the transition period of the new Regulation.

Will your product be reclassified under the new MDR?

As a result of the current proposals, some devices will be reclassified into a higher risk category. For these devices, the scrutiny of the technical documentation by the Notified Body will increase considerably. It is therefore necessary for manufacturers with devices impacted by this change to be prepared and be aware of the implications of this regulatory change on their technical documentation and placing of the product on the market.

This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements.

Listen back

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.