Countdown to MDR Enters the Final Months – A Summary of the EU’s Biggest Regulatory Changes in Decades for the Medical Devices Sector

The new Medical Device Regulations (EU) 2017/745 (the MDR), the biggest regulatory event in the sector for a quarter century, will become fully applicable on 26 May 2020, replacing the current Medical Devices Directive (MDD). The MDR will have significant implications for all economic operators in the medical device supply chain.

The MDR expands upon the current regulatory obligations and responsibilities for all economic operators to include manufacturers, importers, distributors and authorised representatives. In this article we explore just some of the practical implications of the introduction of the MDR.

Classification

Devices are classified into four classes based on their risk profile with Class I being the lowest risk and Class III the highest. The MDR sets out 22 rules which are to be used to classify devices and which will replace the 18 rules currently used under the MDD.

The classification of a Device directly influences the pre-market requirements, conformity assessment route, clinical data requirements and post market obligations associated with that device.

It is important to note that the MDR will not only affect the classification of new devices but also introduces changes to the classification of certain existing devices which will result them being ‘up-classified’ and thus subject to stricter regulatory requirements.

Clinical Investigations

The MDR significantly enhances and provides clarity as to the requirements for clinical investigations and aims to drive improvements in both the quality and quantity of clinical data available for medical devices. For example, the MDR provides much greater detail than the MDD in relation to the design, conduct and reporting of clinical investigations and will require that a clinical investigation report, summarising the study results, is made available to the public.

In addition, due to the ‘up-classification’ of some devices under the MDR, clinical data under the MDR will be required for an increased number of devices. Whether that data is collected on a predicate device, during pre-CE clinical trials or during post-market clinical follow-up studies, this is likely to represent a significant challenge for most manufacturers.

Vigilance

The MDR marks a major change from the MDD in terms of providing a solid framework that seeks to ensure the safe and effective use of medical devices across Europe. As part of these changes, the MDR reinforces the principles of post-market surveillance in a manner proportionate to the device risk. Consequently, for the highest classes of risk, manufacturers must actively and regularly communicate the results of their post market surveillance activities with their Notified Bodies and make that data available in the new European medical database (Eudamed). For the lowest classes of risk, Post-Market Surveillance records must remain available upon request and updated with a suitable frequency (e.g., every two years for Class IIa).

Distributors will also play a central role in the vigilance process as they are required to keep a register of complaints, non-conforming products, and product recalls and withdrawals and must ensure that the manufacturers are informed of any complaints or reports that may have an impact on products supplied to the market.

The MDR is one of the most significant regulatory changes for medical device manufacturers, distributors and importers in decades. The May 2020 deadline for the MDR means that the clock is now ticking for all economic operators in the medical device supply chain to implement the necessary process changes for compliance.

How we can help

BHSM’s Healthcare and Life Sciences Department offer practical legal and regulatory compliance advice to a variety of clients across the medical devices sector.

For further information on how the introduction of the MDR may affect your business, please contact David Scott in the Healthcare & Life Sciences Department of BHSM on 01 440 8300 / dscott@bhsm.ie.

This article is for general information purposes.  Legal advice must be obtained for individual circumstances.  Whilst every effort has been made to ensure the accuracy of this article, no liability is accepted by the author for any inaccuracies.