The new Medical Device Regulation applies to all legal manufacturers of medical devices, as well as importers and distributors of medical devices that are to be sold on the EU market. The European Commission describes the new MDR as “… necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific developments in the sector”. How the new MDR is to consolidate the EU as a global leader is very difficult to see.
This article discusses a selection of changes in the new MDR based on what changes are good and bad for the public and manufacturers. Please note, some of the requirements and principles brought up can be argued to have occurred before the MDR, for example where they have been implemented in MEDEV documents, but are now in the actual regulation.
The good changes in the 2017/745 MDR
There are in particular three changes in the new MDR that are for the better. We will take a closer look at these changes below.
Technical documentation according to the MDR
If you have been working in the medical device industry for some time, you have most likely come across the term technical file. The problem with the technical file and the old medical device directive is that it is not particularly well-defined what should be included in a technical file and not. This has left the field open for interpretation, and different entities have had different views on what the contents of the technical file is. This is not the intent of a common market in the EU.
In the new MDR, Annex II and III of the regulation describes in quite good detail what shall be included and not. This removes the uncertainty and makes life easier for manufacturers, so that they know what they should do in this regard. Albeit, it is not a revolutionising change, but it is most certainly a change in the right direction.
The inclusion of non-medical devices in the MDR
There are two things that determine whether a product shall be considered a medical device or not. These are the intended purpose as defined by the manufacturer and how the product achieves its primary purpose.
In short, if there is a therapeutic purpose or if the product is a contraceptive and does not achieve its primary purpose by metabolic, immunologic or pharmacologic means, it is likely a medical device.
This means that for example fillers that are intended to be used only for cosmetic purposes or contact lenses that do not correct vision, but only change the eye colour are not intended for medical purposes. Therefore, these are outside the scope of the medical device directive.
Equipment for liposuction have been possible to place on the market without being medical devices. However, in Annex XVI, there is now a list of products that do not have an intended medical purpose. These will now fall within the scope of the MDR, and more specifically article 1(2).
The result of this means that manufacturers of for example coloured contact lenses will have to comply with the requirements of the MDR, as well as any harmonised standards that apply to analogous medical devices that do have harmonised standards.
This is great news for a consumer buying cosmetic products, since these products are now regulated and likely safer.
Clearer requirements on QMS
Annex II to VII in the MDD outlines the requirements on quality management systems depending on if the classification shows an assessment route, or anything but complete.
Luckily, the requirement on quality management systems has been clarified in article 10, and now contains a list of things that must be addressed. This is not too far from the requirements and ISO 13485:2016 and makes it easier to understand what actually needs to be implemented and not.
Class I manufacturers must have a full QMS
The new MDR makes no exceptions for having a QMS for manufacturers of class I products. This is a pretty reasonable change. This means that the chances of class I manufacturers knowing what they are doing have increased. It also means that class I manufacturers have to apply design control requirements for the development of both physical as well as stand-alone software products.
The bad changes in the 2017/745 MDR
In addition to the changes in the MDR that can be considered improvements, there are also several changes that are not so positive. We will be looking at a selection of these now.
The name of the general safety and performance requirements
In the Medical Device Directive, Annex I contains essential requirements. All medical devices have to comply with the essential requirements that apply to them. In the MDR, for whatever reason, the essential requirements have changed names to General Safety and Performance Requirements.
A very unnecessary change from my point of view. It might seem like a small thing, but do keep in mind that these two different terms for basically the same things are not the only ones. In the machinery directive, the requirements in Annex I which are equivalent to Essential Requirements of General Safety and Performance Requirements, are called Essential Health and Safety Requirements and relate to the design and construction machinery.
The lack of harmonised standards
Article VIII of the MDR states that devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards shall be presumed to be in conformity with the requirements of the medical device regulation. This is excellent news!
It is similar to what has been done in the last 25 years with the Medical Device Directive and harmonised standards. Now, the only problem is that with less than one and a half month left to the original deadline for the implementation of the MDR, there are still harmonised standards published in the Official Journal.
This means that manufacturers themselves need to provide rationales on why they use certain standards that are harmonised with the Medical Device Directive, but so far not with the MDR to achieve conformity with the general safety performance requirements of the MDR.
This is an incredible waste of resources, where thousands of medical device manufacturers are busy thinking through the same things in many places. The harmonisation of standards with the MDR should have been taken care of long before anyone submitted technical documentation to any notified bodies.
The lack of notified bodies
All medical device manufacturers of some class I products and class IIa and higher products must have a notified body and go through a certification process with them. If there are no notified bodies, or insufficient numbers of notified bodies, this will lead to delays in reaching the market.
Both small and medium-sized enterprises report that the lack of accredited notified bodies results in huge delays, not only months but years to get a new product CE marked. This is of course a complete and utter failure in the implementation of the MDR, where patients in the EU will have to wait longer for what has to be assumed to be better and newer medical devices, compared to patients in the US.
The patients will not only suffer but, the financial ramifications on small enterprises will be significant and job opportunities lost.
The regulatory responsible person
The new MDR requires at least one person in the organisation to be formally assigned responsibility for ensuring the regular compliance of the manufacturer. This is not completely new, because manufacturers have been required to have a management representative for many years and responsibilities are usually assigned to QA managers or the like. But, in the new MDR, there is a greater emphasis on personal responsibility, which at least by some is interpreted in such a way that you as a private person could be held responsible instead of the legal manufacturer or employer.
For small companies, it is permitted for this person to not be an employee, which we should be thankful for, but how many consultants are prepared to take on the responsibility of being that regulatory responsible person?
Most consultants would have a hard time finding insurance that would cover situations where they made a mistake in this position that might lead to harm for thousands of patients. I do not mind the requirement of having this role or responsibility defined, but personal responsibility is a great concern leading to many difficulties for mainly small and medium-sized enterprises.
The scrutiny process
For class III products and active class IIb products intended to administer and/or remove a medicinal product, the product may end up in a scrutiny process with an expert panel and competent authority.
This means that an additional review will be done of the technical documentation of the product at hand before CE marking. This in itself is not a problem, but the expected time this may add to the time-to-market is a real concern.
The classification of software, has been described as a “…wet dream for consultants working in the field” because it will take years before there is a common understanding of how this classification shall be done. People working with the guidance document for interpretation of the MDR, have jokingly said that they might need a guidance document for how to read the guidance document for the MDR.
The confusion relating to this will take a tremendous amount of time to sort out before there are common practices established across the world and an interpretation of this. Furthermore, several apps that are relatively harmless, will now become classified as class IIa medical devices or higher, further increasing the cost and reducing access to this type of apps.
In some areas, the new MDR will without a doubt improve safety for the public. In conjunction with that, one can be seriously concerned about the cost of those improvements.
By cost, I do not only mean increased expenditure for the medical device manufacturers and possibly the European public when buying medical devices with increased prices, but also costs related to delayed access to novel and improved therapies.
Risk management is a crucial part of the MDR and design control requirements will also apply to class I manufacturers.
Would you like to learn more about Risk Management?
Get instant access to our online Risk Management for Medical Devices and ISO 14971:2019 course right here. In 6 hours, you can learn more about how to develop new medical devices and maintain them in organisations where design control requirements apply. This course is taken by quality assurance, project management, design engineering or those involved in R&D and product development teams.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.