This regulatory topic has become increasingly pertinent, ahead of the countdown to the EU’s new medical device and in-vitro diagnostic rules, set to take effect on May 26, 2020 and 2022, respectively.
Currently, there are more than 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Robust regulation that ensures a supply of safe devices, and allows monitoring of the introduction and use of medical devices, is essential.
The new Medical Device Regulation (EU) 2017/745 was published in the Official Journal of the European Union and came into force on May 5, 2017, replacing two existing Directives:
1. Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
2. Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017 on in-vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
The new regulations apply after a transitional period. Namely, three years after entry into force of Regulation (EU) 2017/745 on medical devices (May 26, 2020), and five years after entry into force (May 26, 2022) of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices.
Existing devices which have been CE marked under the current Medical Device Directive (MDD) must be recertified to abide by the new MDR.
The new regulations aim to enhance patient safety and modernise public health, by introducing an enhanced governance framework around the definition, supervision, traceability and risk-based classification system for medical device equipment.
Some key elements of the new legislation include:
Medical device manufacturers must prepare for regulatory changes
During the present transition period up to May 2020, manufacturers can choose to comply with either the existing MDD/AIMDD legislation requirements, or the new MDR.
However, as all medical device products marketed in the EU must eventually comply with the MDR, and any changes to pre-MDR products after full application of the MDR negate MDD compliance, companies are advised to define their strategies for regulatory transition.
Comparing and contrasting regulatory differences between the existing MDD and the new MDR is important. As it is highly likely for most legacy devices that a review of MDR requirements will identify regulatory issues that will need to be addressed for every device.
Complying with the new MDR will prove a high task for most medical device manufacturers. Guidance and implementing measures under the current Directives will be reviewed by authorities over the next few years, in light of the new regulations.
At this present stage, the European Commission has a published list of legally non-binding guidance documents adopted by the Medical Device Coordination Group, to support the industry’s efforts to apply relevant provisions of the MDR. These include consensus statements, informative documents and MEDDEVs for medical device manufacturers, authorised representatives, notified bodies, and competent authorities.
In addition, on October 30, 2018, the European Commission published the most recent version of the Borderline & Classification Manual. This document provides guidance on establishing the status of medical devices and IVDs, as well as their risk classifications. The current version, version 1.20, replaces version 1.19 released in April 2018.
The new medical device regulations in Europe present a huge challenge to manufacturers, but could also deliver improved confidence in the consistency and effectiveness of the EU regulatory process.
By Cliodhna McDonough
Source: Pharma Times
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