MDR is the Mother of all disruption for the Medical Device Industry, but will Brexit & UKCA be worse?

DON’T PANIC KEEP CALM MR. MAIINWARING!

Since the early 1990s, medical device organisations wishing to sell their products in Europe have been complying with the Medical Device Directive (MDD). These regulations have caused medical devices to become more standardised, aided by this common law. Which then facilitated the free movement of medical device products across borders, without further inspection. For some time, the MDD has been under review at the European Commission, throughout its duration there have been some high-profile cases, where the regulations have failed to stop substandard products getting into the market. Some examples are breast implants, hip replacements, and surgical mesh. As a result of this, the regulations have been broadly criticised for not being strict enough, to protect patients from rogue devices placed on the market. Some manufacturers outside of the European Union, and some within, have used the design input of a predicate device. They brought products to the market, without taking on the responsibility, to test rigorously the effectiveness of those devices after they have created them. Choosing equivalence as the major pillar of their design input, which will no longer be acceptable in the EU.

Various MEDDEV documents were produced throughout the life of the MDD, their function was like software patches for an operating system, that was not right when launched. How many of you reading this post, remember Microsoft Vista®? The Medical Device Regulation EU 2017/745 (MDR), is the new Microsoft Office 365®. It has incorporated all of the patches from the previous directive to create a better statute. Because of the experience gained by the European Commission, the MDR is more robust and complete in the way it regulates the placement of medical devices on the market in the EU.

There are some significant changes when comparing the MDD to the MDR, products that have a higher risk will be expected to undergo greater premarket scrutiny, involving clinical subject experts. This new encompassing function gives the notified bodies greater support, to make better judgments on technologies or techniques, they do not have the expertise to give guidance on. The governmental management of notified bodies has also been enhanced in MDR, as the relationship although symbiotic, between the notified bodies and the medical device companies (their clients), theoretically could be open to abuse as the client pays the Notified Body to issue them with the CE mark. 

Implantable devices will require the provision of a patient card, so that the device recipient will know exactly what has been left in their bodies. They can use this card in a number of places e.g. when travelling, when being attended to by a paramedic or when changing primary care physicians. One of the most challenging enhanced requirements of the MDR, is a greater focus on clinical evidence. It will no longer be acceptable for companies to prove that a device acts in the way it was designed alone. If the intended use implies or is designed to impact the patient’s treatment outcome, passing a safety study will not be enough. The MDR has a greater focus on how these devices assist the patient’s treatment pathway, and whether the device effectively treats the patient by improving their clinical outcomes.  

This highlights some of the practises in years past when organisations used predicate devices as the foundation for design input, citing substantial equivalence as an argument to place a product on the market. The increased requirements for enhanced clinical evidence on some classifications, will inhibit the predication argument to some degree. This will create a barrier to trade in the EU27, for those companies who simply copy devices, by merely changing manufacturing processes and maybe tweaking the selection of materials. These companies were sometimes able to bring product to the market at a lower cost, which added value to procurement and large GPOs, as they used these products as a negotiating weapon to bring pricing down. Will these disruptors be held to a higher standard under MDR? Only time will tell.

However, there are a couple of other political and regulatory tsunami’s coming, the first of them will be Brexit which supposedly takes place on the 31st December 2020. An agreement exists in principal, but the negotiation is still not finalised. Looking forward, there is still a chance that in six months the UK could find itself without a clear agreement, even though the UK parliament has statute in place to prevent this.  What happens then? At that point the United Kingdom will no longer be subject to the laws of Europe, all British goods will be checked at the border and the same will happen to goods coming in from Europe.

Any company that has been awarded the CE Mark by a UK notified body, will lose their accreditation immediately, their certificates will become void. However, the UK will continue to accept CE Marked product. The last meeting of the Public Bill Committee was on the 10th of June 2020. The committee has closed the book on further written evidence in regard to the new UK bill, which will be called the Medicines and Medical Devices bill 2019-21. The bill is now due to have its final report stage and 3rd reading on the 23rd of June 2020, however amendments can be made to the bill at the report stage. In recent webinars hosted by the UK government, it has been proposed that there will be a term time of mutual recognition which may last up to 24 months, saying in the short term medical device organisations will be protected and their ability to move products across borders will not be inhibited.

Medical device organisations should be raising concerns with government through their trade associations, because they will need to comply with two sets of regulations in Europe and absorb the cost of this expense. In the short term, it is reasonable to assume that the UKCA mark will bear many of the requirements contained within MDR. Medical Device Senior Leadership have lost many sleepless nights pondering on how to be ready for MDR. Yet we are six months away from the UK leaving the European Union, and there is not a lot of guidance available on what needs to be done to comply with the new UK Conformity Assessment Mark. The story of COVID-19 has dominated the news cycle, and rightly so, but we cannot forget that BREXIT will have a health and well-being impact on many citizens. Consider this; because of the delay due to COVID-19, the irony is that the UKCA mark could be enforceable if there is no agreement, before the Medical Device Regulations which have been postponed until the 26th May 2021.

How will medical device organisations prepare and respond to this mammoth change? How will the government raise the awareness of the manufacturing companies, both in the UK and outside of the UK? Will our Prime Minister run his hands through his uncombed hair, smile broadly, and say, “We were only joking!”. This post cannot answer these questions, it only seeks to formally raise them so that they can become a point of discussion. Initially all of the Notified Bodies who are delivering accreditation for the CE mark will be appointed for the UKCA mark, but none of them will be UK based. It’s a little bit like applying for a British passport, but having it issued in Brussels. So, don’t worry Mr Mainwaring your new independent mark will be assessed by, and issued by European cousins.

Is this REALLY Brexit!?

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