May 26, 2020 is the Date of Application for the new EU Medical Device Regulations. The industry has not embraced these new regulations. They are found to be overly intrusive, to stymie innovation, to raise cost and result in products being taken of the market. Besides the fact that MDR itself is not ready: EUDAMED is delayed and many guidance while expected are still not available. What’s a company to do in these uncertain times? Nevertheless, our 2020 Outlook is positive.
Are you Ready? Is MDR Ready?
As MDR is here to stay, those companies that embraced the change and considered it an opportunity are winning out. They developed solid strategies and are now executing tactics that are sure to put them ahead. None of this came without putting in a lot of effort and resources.
2020 and forward will allow them to rise.
How about 2019?
We ourselves are also strategizing towards making the next few years gamechangers, albeit on a smaller scale. But, before I tell you about 2020, let me tell you about 2019.
This year we were involved in several projects. Some of these projects involved components I had not earlier been exposed to.
As a matter of fact, several projects caused me to get involved in clinical affairs: one of them, a project in the vascular space required showing why clinical data gathered in China would be/would not be of significance in Europe. We contributed by handling the collection and data review in Europe.
Another required the review of MAUDE data as well as complaint date as part of an annual Clinical Evaluation Report update. This project was the reason we created an “always up-to-date” replica of the entire FDA MAUDE database. As a result, we can now run any query with an unlimited number of response records for our customers.
Another project concerned a company that anticipated an FDA 522 order. We developed a project plan, forecasted cashflow and generated financial impact based on quotes from a multitude of CRO’s.
The exposure to the clinical impact of our customer’s products helps us better understand how their products are used, the impact they have on the patients they serve and the concerns of the healthcare providers. This better understanding helps us better serve our customers.
And our 2020 Outlook?
We have been working on 2020 for several months now. Our 2020 outlook is to further tighten our relationships across Europe and the US. To help our US customers enter Europe, it is important that we keep and further develop close ties within the EU community and the UK. It is equally important that we maintain strong relationships with the US Medical Device community.
Of course, 2020 is the year MDR comes into full effect. Many of my friends in Regulatory Affairs are working frantically to help Medical Device companies prepare for May 26th, 2020. As Chair of the Professional Liaison Committee of the Orange County Regulatory Affairs, discussion group, I know many of our 350+ RA/QA/CA members crave information about MDR. And I expect this to remain a focus of my attention for the next few years.
I am very pleased with our accomplishments this year and our 2020 Outlook is very positive. Without a doubt, we will again have a great opportunity to exceed our customers’ expectations, setting us up for an even greater 2021.