EU-MDR TRANSITION: Effective Revision and Implementation

INTRODUCTION

Beginning in May 2017, the new Medical Devices Regulation (EU-MDR) was published in the Official Journal of the European Union. Manufacturers, suppliers, notified bodies, and national competent authorities will have a three-year transition time from now to comply with the new regulations that will go into effect within 26 May 2026. The size of the changes made puts pressure on all impacted parties to carefully review the MDR, determine how it will affect their own organisation, and establish compliance processes and procedures in accordance with that assessment. Non-compliant businesses will lose their CE mark certification after 26 May 2026, and restrict their access to the European market.. It is equally challenging for notified bodies to comply re-designation process. Both these put together, not only delays the MDR compliance of existing products but newer medical devices too.

Since the MDR was released in 2017, several regulatory professionals have written and distributed materials with the goal of assisting businesses in comprehending the new regulations and modifying their organisational structures accordingly. While many of these resources are quite helpful, we set out to provide something unique with this comprehensive guide in the hopes that it will be even more beneficial. In addition to identifying some of the key components of this new Regulation that will probably necessitate action on the part of regulated enterprises, we also provide a transition strategy that may be customised to meet the unique requirements of your organisation.

It's crucial to remember that given the scope of these changes, it may be beneficial—and even necessary—to enlist the aid of a third party consultant who can offer a perspective informed by prior experiences and a thorough understanding of MDR in order to create your transition plan and implement it across all affected areas of your organisation.

MDR: Key Changes

· The Medical Device Directive (MDD) was replaced with a new rule that is four times longer and has five additional annexes.

· The MDR contains the term "safety" 290 times. In contrast, the MDD only used it 40 times.

· In order to execute the necessary modifications to stay compliant, corporations will need to rationalise their portfolios and conduct a worldwide impact assessment due to the new law's significant phrasing changes.

· For the majority of historical devices (CE-marked under the MDD), Annex I, General Safety and Performance Requirements, highlights additional circumstances that will need to be handled. Existing items need to receive a fresh certification in compliance with the new rules.

· Most businesses will be required by the new regulations to update technical documentation, labelling, and clinical data.

· All labels must include the Unique Device Identification (UDI) that will be used to trace devices throughout the economic operator supply chain.

· Despite the fact that medical devices and AIMD were beyond the MDD's purview, they are both covered by the MDR.

· Non-medical and cosmetic gadgets that were not previously regulated will be included to the definition of medical device. Examples include contact lenses, liposuction tools, or lasers for epilation as well as items for cleaning, disinfecting, or sterilising equipment.

· To support safety and performance claims, manufacturers will need to produce and share more detailed clinical data, as well as adhere to stricter equivalence criteria.

· For patients to have access to additional safety-related information, manufacturers will be required to report all events, injuries, and fatalities to an EU site that would centralise pertinent data. The reporting period has been shortened from 30 days to 15 days for occurrences that did not cause death or a substantial decline in health.

· Organisations going through a transition will need to review their fundamental procedures, such as quality control, risk management, and post-market expectations. These will need to be thoroughly examined, planned, and updated in order to be re-implemented in accordance with the new criteria.

· A new categorization for reusable surgical equipment that calls for notified body monitoring and the reclassification of several medical devices into a higher risk class.

· In contrast to the present 10%, IVDs are now divided into four risk categories that will require Notified Body evaluation for 90% of the devices.

HOW ARE THESE CHANGES GOING TO BE APPLIED?

The revised deadline for completely implementing these reforms is 26 May 2026 for medical device businesses.

It's vital to emphasise that European governance has been enhanced to guarantee that the laws are implemented and respected because many of the new legislation represent a considerable transformation. Having been established, the Medical Devices Coordination Group (GCDM) will be in charge of implementing the laws by using a "scrutiny mechanism" that will enable them to examine a Notified Body evaluation of high risk devices. Notified Bodies' function will expand. They will conduct testing, sample checks, and arbitrary audits.

Additionally, producers must designate at least one individual to be in charge of regulatory compliance, who will make sure that the new rules are followed. They will be comparable to what is known as a Qualified Person in the pharmaceutical sector.

WHERE AND HOW SFO TECHNOLOGIES ASSIST IN THE TRANSITION

· Preparing and managing projects

MDR's scope of change will need clever, effective project management to guarantee that tasks are properly completed on schedule. A third party compliance expert's viewpoints and past experiences are ideal for this particular function. From this elevated vantage point, a consultant may make use of their skills to create a transition strategy and see it through to completion by using best practises and directing project teams at each stage.

It is simple to convert a transition plan created by a professional into a project checklist and set a timeframe based on realistic expectations that are informed and backed by actual experience rather than estimates.

· Project duration

By considering a number of situation-specific elements, third party specialists can also help you prevent a possible regulatory disaster brought on by bad timing.

For instance, it's crucial that businesses plan their auditing efforts with their Notified Body not with the compliance date in mind, but rather the date by which the Notified Body will acquire proof for compliance. Given the buffer period you might need to put remedial steps in place and the fact that the implementation of the EU-MDR is required by May, for example, and your Notified Body generally audits during the month of March, you should be able to carry on as usual. If, however, audits are performed in October, you will need to be audited six months before the requirements must be put into practise. Based on the regular audit pattern of your Notified Body, an independent consultant will be able to pinpoint a specific position on the calendar to start and conclude transition.

· Assessing gaps and rationalising the portfolio

An extensive gap assessment is carried out by knowledgeable experts who arrive with a collection of checklists and instructions. When rationalising your portfolio, consultants may also be a great asset, and have supporting paperwork assessed by a Notified Body. Similar to this, gadget modifications call for evaluations in order to keep their certification. One of the major challenges for medical device companies, that we see, is the maintenance of legacy devices. These devices could be premium products sold at low volume or affordable products that have a larger market reach.  In either case, the decision to withdraw the product from market for not complying MDR is hard hitting. Many a times it is the in-house resource shortage or limited documents that puts companies in predicament to recertify the product. This is where SFO can be found resourceful.

Know more about how SFO Technologies can help you glide through these steps of the transition!

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