EU MDR Implementation: a Presentation to OCRA, Orange County Regulatory Affairs discussion group (Part 1 of 3)

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 1)

From MDD to MDR

Over the past few years manufacturers paid a lot of attention to the new European Medical Devices Regulations and the challenges and opportunities created by the changeover from the Medical Device Directives to the Medical Device Regulations.

A major change such as the one we are facing presents both threat and opportunities.

Even though the majority of companies are well on track and actively working on the transition plans, many companies are woefully unprepared. For these companies MDR will be a threat.

At the same time, I expect that certain companies are viewing MDR as an opportunity to get ahead of their competitors.

Whether this change over is more of an Opportunity or a Threat for your company, one thing is for sure: the changeover presents not only a regulatory challenge, it basically presents a business challenge to the entire company.

3 business impacts of MDR

As a business development person, I tend to look at the MDR more from a business standpoint than a Regulatory or Quality Assurance standpoint. In the following paragraphs, I will address the MDR from three perspectives:

               Cost. Obviously, you are in business to make money, and making money costs money. How much you spend to make money is the basis of a healthy business.</li>

               Strategy. Businesses operate in a competitive market. The strategy you pursue determines whether you eat or will be eaten.</li>

               Timing. The MDR has a short implementation time. It is only a year away. And there are still many unknowns.</li>

But before I get to these three perspectives, let’s talk about MDD.

MDD was a huge success…

The MDD was published in 1993 and became a tremendously successful program. The program often received praise as one of the fastest ways to Market.

In my work I often meet CEO’s of small MedTech companies and start-ups. As you know, VC’s like to invest in companies with proven teams. That’s why you often find CEO’s at the helms of these companies that have done this before. To this day, the majority of those CEO’s tell me they want to get CE mark first.

MDD made a very good name for itself. The FDA was often blamed for putting obstacles in the way of innovation. In the eyes of many. MDD had less obstacles.

… till MDD had to go

Unfortunately, around 2010, a scandal in Europe caused a lot of pain and anxiety for a lot of people. A French company called PIP (Poly Implant Prothèse), manufactured silicone breast implants. While the FDA had issued a voluntary moratorium for these silicone implants in 1992, the EU authorized them in 1997. In 2000 the FDA visited the PIP plant for an inspection and followed up with a warning letter for deviation from GMP. Then in 2001 the company decided to replace the medical grade silicone for their breast implants with industrial grade silicone. By 2010 these implants were leaking at a rate five times higher than others.

Years later, victims received compensation not enough to cover the removal costs of the implants. Imagine the optics: the FDA had successfully shielded the US public from this malicious operator. The EU had failed.

As a result, what had started out as a modest upgrade of the MDD, morphed into a extensive rewrite into the MDR.

Directives vs. Regulations

The Directives were exactly that: directions from the EU commission to the 28 member states to codify the directions into law in their member states. These directions were limited and left some room for interpretation by the individual member states and competent authorities leading to different implementations. The EU commission decided to replace the Directives with Regulations. The Regulations are laws implemented at the EU level, eliminating the need for interpretation and codifying at the member state level.

I am sure that most of you have thoroughly read through the MDD and the MDR. In comparison the MDD is a small document. A mere 23 articles and 13 annexes. The MDR is a good 170 pages, 13 articles and 16 annexes.

EU MDR Implementation; a Presentation to OCRA, Orange County Regulatory Affairs discussion group (Part 2 of 3)


EU MDR Implementation; a Presentation to OCRA, Orange County Regulatory Affairs discussion group (Part 3 of 3)

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