ISO 13485:2016 Content Library

CE Marking - What is the Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) is a new regulation governing the safety of medical devices available in the European Union (EU).

Work on the new MDR began in 2012 following the Poly Implant Prothèse (PIP) breast implants scandal.

The new Medical Device Regulation was published on 5 May 2017 by the Official Journal of the European Union. This new regulation – known as (EU) 2017/745 – replaces and repeals both the existing Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC.

Keep a pulse on the latest in medical device regulations

With the medical regulatory landscape having undergone it’s most significant overhaul in years; comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation.

Medical Device Regulation - Are you prepared for the changes?

The European Union (EU) regulatory framework for medical devices consists of the Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC.

In the interest of simplification, both directives are combined under the MDR, which is introduced as a regulation instead of a directive, following a proposed revision by the European Commission on 26 September 2012.

A regulation was deemed the appropriate legal instrument as it imposes clear and detailed rules which do not give room for different interpretations by member states.

How To Classify Your Medical Device - Classification Rules

To win in the highly regulated and high stakes world of medical devices manufacturing, it is crucial to beat the competition to the market, and minimise any potential losses from surprise product launch delays.

Our thorough yet streamlined approach ensures you get the right type of guidance at any stage of the product lifecycle, towards a timely market launch.

ISO 13485:2016 Overview

ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. Transition to the new standard must be completed by March 2019, and with that in mind medical device manufacturers are seeking clarification on how to implement the new requirements before the deadline.

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