Final Draft Text of MDR now published

The final text of the Medical Device Regulation, which will replace the current Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC), is now published. 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.

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, once adopted by the European Parliament and by the Council, replaces the existing three Medical Device Directives.  


When are the Medical Device Directives changing?

The Council has planned to approve the agreement at ministers' level in September 2016. Following their legal-linguistic review, the draft Regulation will be then adopted by the Parliament and the Council, expected in May or June 2017.

The new rules will apply 3 years after publication for medical devices.

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


Informative BSI white papers

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 complementary copy now.

 

 

 

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. Register and download this white paper

 


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.