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Peter Rose

FDA Compliance

Wake-Up Call: Class I Manufacturers, Get an Early Start on EU MDR Compliance

A tardy response will be costly and painful

Published: Wednesday, September 4, 2019 - 12:01

On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and be fully compliant under EU MDR.

This statement alone may be surprising to certain Class I manufacturers, who assume that their products’ classification as low-risk devices under the previous directive will exempt them from all this EU MDR commotion. These presumptions are misguided because classification requirements listed in the EU MDR are relevant to all manufacturers, irrespective of past classification.

With this deadline in sight, it is crucial that all manufacturers familiarize themselves with these regulatory changes and promptly make a start on implementing necessary measures. Those that fail to achieve compliance on time will be left behind, and their products removed from the market. In light of this industry bustle, this article aims to advise Class I manufacturers about the primary alterations that the EU MDR will enforce, as well as offer practical steps that manufacturers can begin to follow.

Establish device classification

Under the EU MDR, many existing classification rules have been significantly revised, and while the medical device directive contained only 18 rules, the revised EU MDR is comprised of 22 rules. With these four new rules in place, manufacturers may find that additional classification rules are applicable to their devices. We suggest that manufacturers begin their compliance journey by first reviewing EU MDR Annex VIII to assess any potential new conformity-assessment routes that may be required for their product range. Some products may be up-classified to another subsection of Class I or Class IIa, IIb, or even Class III, while others may be subject to medical regulation for the very first time.

Examples of products affected by this restructure include spinal products (MDR Annex VII, rule 8); standalone software (MDR Annex VII, rule 11); products without an intended medical purpose (Annex XVI); and Class I reusable surgical instruments (Article 52 (7c)). Expanding on this last example, reusable surgical instruments will now fall under a new category known as Class Ir, which contrary to its previous classification, requires input from a notified body. In parallel, products in circulation that entered the market prior to an applicable standard, directive, or regulation will also require a new CE mark, since grandfathering of products is prohibited.

Avoid assessment gridlock

Once device classification is established, it is crucial for businesses to lay down a timeline in order to effectively plan and execute the next stages of the operation. While non-Class I manufacturers that have been recertified under the medical device directive before the 2020 deadline may benefit from an extended deadline up to 2024, Class I manufacturers have not been accorded such a margin for maneuver and consequently cannot afford to fall behind. The urgency of the matter is further enhanced by the shortage of notified bodies throughout Europe, with only three notified bodies presently designated under the EU MDR, which means that regulatory expertise will be scarce. Whilst it is expected that this number will rise to 16 to 20 by the end of 2019, these organizations will nevertheless find themselves immensely overstretched because the volume of cases awaiting review will largely outweigh their capacities.

Facing such a high demand, notified bodies will be much less available for any kind of additional support or input, which may motivate some manufacturers to seek regulatory expertise elsewhere to guarantee a smooth compliance process. Moreover, as the outcome of Brexit remains uncertain, manufacturers are advised to engage an entity and potential authorized representative within the EU 27 to ensure they are as equipped as possible to cope with the possible effects.

Although some medical device manufacturers may have already initiated implementation efforts, others will require more assistance and guidance to bring their compliance plans to fruition and should begin the process as soon as possible to avoid delays. Given that most Class I manufacturers are presently self-certified, they are unlikely to possess internally the relevant quality management system or clinical data to attempt to independently comply with the MDR.

Build in time for a post-market surveillance report

As part of their quality management system, Class I manufacturers will now also be required to prepare a formal post-market surveillance report. This post-market surveillance report should result from a post-market surveillance procedure and documented plan, and must be a continuous, proactive process with the objective of improving patient safety. It should also support the updating of clinical evidence, as covered in the MDR’s Article 85. As such, manufacturers should not underestimate the time, preparatory work, and resources that will be required to meet these regulatory requirements within the set times, particularly for businesses engaging with notified bodies for the first time.

Start the process now to avoid trade repercussions

Class I manufacturers that delay their EU MDR preparations are putting themselves at risk. As a priority, manufacturers should find out which classification changes may impact the compliance requirements for their products. In a second stage, manufacturers should immediately seek out a notified body to review their technical documentation and achieve CE marking, before they reach full capacity. In light of the scarcity of notified bodies, it is also recommended that manufacturers reach out to other organizations for their regulatory expertise, particularly for Class I manufacturers that are affected by medical device regulations for the first time.

If the deadline is not met in time, manufacturers will see their right to trade on EU markets revoked, causing cash-flow repercussions and damage to both their reputation and market share. To make matters worse, manufacturers who fail to meet the deadline will be unable to collect precisely the clinical evidence needed to complete the technical documentation required for compliance. In order to beat the clock and reach full compliance by May 26, 2020, Class I manufacturers must put EU MDR conformity at the forefront of their priorities to allow for enough time to gather the obligatory clinical data and seek assistance from their notified body. With the deadline fast approaching, it is high-time Class I manufacturers embark on their path to EU MDR compliance.


About The Author

Peter Rose’s picture

Peter Rose

As Managing Director of Maetrics Europe, Peter Rose has worked in the medical device industry for over 24 years, bringing a wealth of experience and knowledge in quality systems and regulatory affairs to Maetrics’ clients. He is a lead auditor and a qualified microbiologist, and has been recognized for his extensive experience with sterilization. In addition to his Maetrics responsibilities, Mr. Rose is also a Director of Medilink East Midlands and has been a guest lecturer at the University of Nottingham, Nottingham Trent University and the University of Sheffield. He is a member of the Technical Policy Group of the ABHI and sits on the MHRA Medical Device Industry Liaison Group. He is a contributor to a number of industry journals and is sought out regularly to speak on industry topics. Mr. Rose holds a B.Sc. degree (Hons) in Microbiology from the University of Sheffield.


Notified Bodies

As regular Class I devices do not need Notified Body certification, I presume the lack of NB's will only affect those Class Is, Im and Ir? 

Notified Bodies - Response

Yes, indeed, the lack of Notified Body capacity will not directly affect manufacturers of Class I, non-sterile, non-measuring and non-reusable medical devices. Do note, however that these devices must still be compliant to the MDR by the Date of Application, including all the associated post-market obligations, even though there is no external scrutiny.

I might add, that we have at least 2 anecdotal examples of a Class I, non-sterile, non-measuring and non-reusable medical device manufacturers having elements of their Technical Documentation reviewed by their certification body as a part of their Quality Management System assessment. Noting that when an organisation who is otherwise a Notified Body reviews a Quality Management System they are acting only as a certification body!