European MDR IVDR: Are You Prepared?

Six months has come and gone since the European Union successfully voted in a considerable set of changes to the medical device landscape. These aren’t just minor changes mind you, they’re going to completely transform the way medical device companies interact with Europe. If you’ve been under a rock for the past six months here’s what you’ve missed:

What Is Changing With the European Medical Device Market?

The Medical Devices Directive (MDD 93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) are being replaced by Medical Devices Regulation 2017/745 (MDR); IVD Directive (98/79/EC) will be replaced by IVDR 2017/746.

Who Does This Apply To?

Anyone with an existing medical device CE Mark or seeking EU approval for a new product.

Why Is It Important I Pay Attention to These New Regulations?

What this ultimately means is if you have a current medical device product being sold in the EU or plan to obtain product approval (CE Mark) for future products you will have no choice but to comply with the new MDR and IVDR regulations.

A Dead Strategy

For decades companies have often chose to commercialize their product first in Europe as the pathway to approval was often less scrutinized than that of a domestic approval via the FDA. Companies could obtain product approvals in the EU, gain market traction and further clinical data, then use that supporting evidence to gain swifter approvals in the US.

When MDR IVDR sets in May 2020 and 2022 respectively the above mentioned strategy will basically cease to exist. Minus some minor differences the approval process of obtaining a CE Mark versus 510k or PMA approvals will largely be one in the same.

A Word To The Wise

The new regulations stand to create a fair amount of havoc in the industry as companies clamor to understand the changes and what it means for their respective businesses. While there are many changes coming down the pipe I believe these four are some of the most important to consider due to the impact they will have:

1.    Legacy Product: No Grandfather Clause - as the new regs set in during spring time 2020 all companies will be forced to adhere to the changes with no exceptions. What this inevitably means is that companies are going to be faced with the harsh reality that their legacy product which has been on the market for years (and the corresponding data and documentation within their DHF) will be out of date or obsolete. There will also be a good chance the new MDR IVDR regs will call for data which was never accomplished when the product originally got its approval as it wasn’t required. As a result companies will be forced to obtain new data points to support their products, a process which may cause some companies to have to evaluated whether or not it is fiscally reasonable to go to such lengths for a product that may or may not be worth the cost and effort.

2.    Limited Notified Body Support – What is highly probable is the amount of companies which are currently approved to audit and award product approvals for CE Mark will decrease as they are unable to achieve the proper qualifications necessary to continue as a Notified Body. In turn this will cause bottlenecks for OEMs attempting to navigate the new MDR IVDR transition. For this reason it is highly recommended that OEMs with an active CE Mark begin their planning for MDR IVDR transition immediately.

3.    Cannot Claim Equivalence – Once MDR IVDR fully sets in no company will be able to obtain CE Mark by ‘claiming equivalence’ to another company’s product. This had previously been an enormous time and money saver for companies who could get product approvals by using industry data which had been done at the expense of another. MDR IVDR states that all companies must own their own clinical data. Companies who used this strategy will now find themselves having to put together their own clinical studies which they hadn’t done prior.

4.    Resources – with every CE Marked product in the industry having to go through a regulatory change of this magnitude at the same time undoubtedly we will begin to see in very short time a shortage of viable, reliable and well suited resources to perform this work. RA/QA folks already are in high demand however this three year transition will do a fantastic job of creating a classic supply and demand scenario where demand for resources is incredibly high yet supply is limited. Word to the wise – protect your RA/QA folks like gold and ensure they know they are appreciated so they are lured away be competitors.

For these reasons and plenty of others I highly recommend companies begin immediately establishing a plan for addressing their transition to these new regulations.

Yes, we have upwards of three years till the first timeline sets in place for product transition and compliance however if you’ve been here before you know that going through major changes of this nature typically doesn’t come easy nor do the governing bodies involved necessarily help streamline the process.  

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