MDR Medical Device Regulation

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

As a manufacturer of a medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are outlined in the Medical Device Regulation (MDR) (EU) 2017/745 and, for the UK, the UK Medical Devices Regulations (UK MDR) 2002.

Further industry guidance and regulatory links are available >
MDR best practice guidelines

MDR best practice guidelines

Download our MDR Best Practices Guidelines to help you prepare and structure your Technical Documentation when planning your application to BSI for a conformity assessment of a medical device under the MDR.

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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), had a transition period of three years. Manufacturers had 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.

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations.

See the latest information on the EU website >

MDR resources to support you

Why choose BSI for your CE marking approval?

BSI The Netherlands is a leading EU Notified Body; we review Technical Documentation as part of a conformity assessment to ensure that medical devices meet the necessary safety and performance requirements to allow them to be placed on the market.

The BSI team has a unique set of expertise from our product and regulatory experience that allows us to provide a rigorous review of your Technical Documentation. This gives confidence in your certification to you and your key stakeholders.

BSI offers Technical Documentation review; you will be assigned a dedicated Scheme Manager to work with you throughout your product certification journey and will remain your point of contact thereafter.

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Digital Week 2021 | Software as a medical device

A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

jmdr articleUnderstanding 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 >