BSI transitions

BSI transitions

Medical Device Regulation (MDR)

Medical Device Regulation (MDR)
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mdr
mdr
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Medical Device Regulation MDR now published

The new European Medical Device Regulation (MDR) has been published in the Official Journal of the European Union. The MDR entered into force on 25 May 2017, marking the start of the transition period for manufacturers selling medical devices into Europe.

What you need to know about the latest MDR

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.

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. 

See the latest information >
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A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

Understanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

Download the article >

MedTech Summit 2020 | EU Medical Device Regulation, Notified Body Overview and Update from BSI

BSI Medical Devices and the of COVID-19 on audits

As the coronavirus COVID-19 outbreak evolves, the safety and wellbeing of our clients and colleagues is our highest priority, so please read our latest updates on how we are managing global audits and assessments.

Read our latest updates >

BSI Medical devices and the impact of COVID-19 on audits

As the coronavirus COVID-19 outbreak evolves, the safety and wellbeing of our clients and colleagues is our highest priority, so please read our latest updates on how we are managing global audits and assessments.

Read our latest update >

BSI: Three Tips from the Top European Notified Body

In an interview with Medtech Strategist, our Senior Commercial Operations Director, Bill Enos, has shared his thoughts on the current pace of the MDR and some tips for manufacturers to be as prepared as possible for the pending date of transition.

Read the article >
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Medical device clinical investigations – what’s new under the MDR?

The conduct of a clinical investigation is one of the most time-consuming and resource-intensive activities that a medical device manufacturer can face. Download this paper to find out more about important new requirements for pre-market and post-market clinical investigations under the European MDR.

Download the whitepaper >