With the EU’s new Medical Device Regulations set to become law in 2020, medical device companies have a lot to do in a short time to comply with the new regulatory framework. To get an expert’s view on why exactly these new regulations have been introduced, as well as what they’ll mean for the industry, we speak to medeuronet co-founder Kristine Morrill.
For almost 20 years, there was little change in how the medical device industry was regulated in Europe. That’s all set to change from 2020. Recent scandals have prompted greater scrutiny from national regulators and the European Union (EU), and have lead the EU to introduce significant regulatory and compliance reforms.
In May, the EU published its new Medical Device Regulations (MDR), which will come into full effect in May 2020. Under the MDR, national regulators will be able to exercise greater control and oversight of the medical devices industry, though the extent of the oversight is not completely clear.
These new regulations will have far-reaching consequences for medical devices companies across Europe, as well as companies looking to enter into the European market. Given the time window for implementation, it’s imperative that companies start preparing now.
With more than 20 years experience in the healthcare industry, Kristine Morrill has a unique insight into what these new regulations will mean for medical device companies, and how they can best prepare for them.
They’re trying to raise standards across the board. There have been past scandals in the medical device industry, none more controversial than the one involving PIP (now defunct). PIP manufactured breast implants, and instead of using medical grade silicon in their implants they used industrial grade silicon. Even though there was never any reported leakages from PIP implants, the silicon inside them did not have a CE mark for use as a medical device. There was a huge outcry for greater patient safety monitoring (In 2011 the French government recommended that 30,000 women have their PIP implants removed).
As a result, the EU initially looked at adopting an FDA-like system, but member states didn’t want to give up their authority. Instead the 28 individual member states decided that there had to be a minimum standard, and that minimum standard is the requirement to have a quality management system in place, which isn’t necessarily a bad thing. What the MDR should do is force out companies that cut corners and don’t do things correctly from the market.
It depends on the classification of the device. For example, if you’re trying to obtain a CE mark for an invasive Class 2A device (or above), you’ll feel the effects of the MDR, but not much beyond the current Medical Device Directive (MDD). However, if it’s for non-invasive Class 1 devices, where the impact will be most acutely felt.
Currently the process for getting a CE Mark for a Class 1 is pretty simple. You just assemble your product, show that it’s both safe and not invasive, and send it to your notified body. Then it’s up to you to do what’s known as a self-certification, which means that your company issues a certificate that states that your device conforms to the current standards, which is the Medical Device Directive.
What the EU has done is raise the bar for Class 1 devices. To ensure greater safety and efficacy, medical device companies will have to ensure that they have a quality system in place – one that is somewhere between ISO:9001 and ISO:13485, which governs medical devices. . To comply with this directive, companies will need to invest in a quality management system, working with a notified body, which will cost between €15,000 to €20,000 to start and then ongoing fees of about €3,000 to €5,000 to maintain certification.
So there’s one significant change. Previously, if you said that your product was ‘substantially equivalent’ with what was already on the market, you didn’t have to provide clinical data to a notified body. That’s not going to be the case anymore for implantable devices. From May 2020, you will need to provide clinical data for your product, prospective clinical data done under controlled conditions, preferably conducted in Europe.
Even now, more than two-and-a-half years before the MDR becomes law, we’re seeing notified bodies request clinical data from companies that aren’t required to do so (as per the current Medical Device Directive) due to the current regulatory environment. Because of the recent controversies, there’s increased concern about releasing a product that may result in harm, and the notified bodies are trying to cover their backs as much as possible. Equivalency can be especially tricky, so they don’t want to take any chances despite the fact that the regulations, haven’t changed yet.
In the current climate, if a company is coming to Europe with a Class 2A device (or above) they should do a clinical study. Another reason for doing a study is to conform to post-market surveillance requirements. Under both the MDD and the MDR, companies are required to report on the performance of their products in the market. It’s never been closely enforced, but this is changing. Now, the notified bodies are enforcing it, and people are scrambling to meet the requirement. Now if you do a clinical study for your CE mark, you’ve got a set of patients that you can continue monitoring. So you’re killing two birds with one stone.
Overall, I believe these new regulations will have a positive impact. Yes, it will cost more up front for companies to address the requirements, but once you do so you’ll find that you’re operating in a much more robust and transparent system. If you’re able to adapt to these changes, you’ll not only stay right for the long haul, you’ll able to market to them as well. Many consultants saw these new regulations and exclaimed ‘the sky was falling.’ That’s not the case, as long as you abide by them.
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