It's May 26, 2021 and seems that the sun is still shining somewhere behind the clouds despite much anxiousness regarding the new MDR (Medical Device Regulation) - as of today it is officially the lay of the land in EU and EEA.
What effect the new regulation has remains to be seen, but in a recent study from Climedo Health, 81% of the 115 companies asked, consider MDR to be “very challenging”. The top challenges include “increased resources and costs” (70%), “lack of clarity” (59%), and “required clinical investigations” (54%). Furthermore, 31% estimate that MDR will cause additional costs of between 5% and 10% of their annual revenue; 13% even believe it will be more than 10%.
There are a number of changes that will cause headache for manufacturers, for example that there will literally not exist any Class I medical device software (SaMD) anymore due to Rule 11; that we have something ambiguous called Common Specifications in addition to Harmonised Standards; that Post Market Surveillance (see earlier blog on this topic) now has to be active and reporting requirements increased drastically, that each company now has to have a Person responsible for regulatory compliance. And so on.
MDR certified notified bodies (NBs) are few and hard to get hold of. Those introducing a medical device to market, or transitioning from MDD to MDR will therefore have to be extra cautions to have all their ducks aligned when a notified body finally comes to audit - non-conformities small or large will have to be addressed at a later point in time... and the question is how much later.
All this costs time and money and there is no doubt that a number of manufacturers (particularly start-ups) will never manage to get their product to market due to unforeseen hinders (see earlier blog on this topic).
It is clear that regulations in themselves are not bad - we want to be sure that medical devices and drugs are safe to use and do what the manufacturer claims they should do. Arguably the incentive behind the 1906: Pure Food and Drugs Act (sometimes also called the Federal Food and Drugs Act - precursor to FDA) was to prohibited interstate commerce of misbranded and adulterated food, and drugs.
Numerous amendments have obviously been made since 1906, including the 1968 Radiation Control for Health and Safety Act, and the 1990 Safe Medical Devices Act (SMDA) - which increased the need for manufacturers to document and report.
Following these amendments however, there have also been a number of amendments specifically to "cut through the red tape" and make it easier for companies to innovate and introduce products to market.
An example of this is the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), where improvements to premarket review times and added shared outcome goals with industry was introduced; a direct De Novo pathway, permitting the classification of novel, low-to-moderate risk devices into Class I or II (rather than Class III) without first having to submit a 510(k) was enforced; Standards changed associated with disapproval of an IDE (investigational device exemption); and the FDA is permitted to work with foreign governments to harmonise regulatory requirements.
Point being that in the US, there have been waves of regulations and amendments - some making it stricter, and some then making it easier and more streamlined for manufacturers to innovate. Is it likely that we will see similar amendments to the MDR over the next years?
Now to the bigger question: when it comes to innovation, will the new MDR have any positive consequences, or does it just present doom and gloom? The short answer to this is (borrowing from legal jargon) "it depends".
What is clear is that companies that care to continue developing medical devices have to "get with the program" at an earlier stage than before - winging it, fabricating minutes of design meetings demonstrating why path A and not B was chosen, creating a graph with the 3 customer complaints found in the email archives, and making late changes to comply to IEC60601-15, is not going to fly.
Manufacturers that have a mindset to spend a larger degree of time upfront to plan and understand the consequences of the decisions made regarding intended purpose, technical specifications, UX, General Safety and Performance Requirements (GSPR), etc. will in all likelihood gain from the increased attention to detail listed in the MDR.
In addition, making better use of post market surveillance to improve their products, will not only improve the offering for the customer but also increase the rate of innovation.
I choose to have a glass half full and say that the MDR might actually have positive effects - but if, and only if, manufacturers plan better upfront and understand the consequences of decisions made.
Xybel offers a webinar on Lean Medical Device Development - that addresses these issues. Please contact us for more information at firstname.lastname@example.org.