These past few days, the European Union’s lack of medical device regulation (MDR) has been highlighted by many news outlets. As a result, the Government faced a lot of criticism: the organization was said to have shown a lack of transparency and a shortage of resources and supervision… It is about time we put some things into perspective.
A renewed MDR
The European Union had recognized the lack of regulation and approved the new Medical Devices Regulation (MDR) in 2017, which will be irrevocably applicable to any medical device starting 26 May 2020. The new European regulation shifts the center of gravity more toward the industry and the authorities involved.
The patient organisations’ cries for more transparency are – rightfully so – getting louder. The Medical Device Regulation responds via its renewed UDI registry (called EUDAMED), which will be publicly accessible for all stakeholders (from industry to patient) on the European Commission’s website. The renewed classification, the UDI, the responsible person, the renewed demands concerning the CER, the stricter post market surveillance reports which also will be made public on EUDAMED – all of these changes in the MDR are beneficial to the patient, but do put an especially heavy pressure on the industry. QbD will be able to help wherever necessary.
Some important changes
First and foremost, the Medical Device Regulation is no longer a directive, but a regulation. This ensures that the local authority is no longer able to interpret the rules as freely when it comes to implementation. This should create more clarity and uniformity in implementing them across all of the European Union. Yet it’s too simple to place all the blame on the local authority. It won’t be that easy to implement the changes, which is why the new MDR has a three-year transition period.
In addition, the industry’s supervisory body becomes the appointed authority, or the Notified Body. Because the European Union enforces stricter demands upon them, there will be less Notified Bodies, although their range of duties toward the industry will expand. This results in a serious challenge when it comes to resources and planning. Also, the Notified Bodies themselves will be supervised as well, which is a plus for the patient. Up until now, their judgments and reports were rarely questioned. They will be dealing with ‘competent authorities’ and a coordination group (Medical Device Coordination Group) that can review and comment on their assessments. Via the NANDO tool on the European Commission’s website, people can check which Notified Bodies can already accredit this new regulation. That means that the bar for doling out certificates will be set a lot higher. It is our expectation that it means the pressure on Notified Bodies will increase. And the Brexit situation won’t have a positive impact in all this.
Also part of the new Medical Device regulation, is that the classification was changed. This means that not just consumer products fall under the regulation (which means there is more to monitor), but existing medical devices are also subject to stricter rules when it comes to safety (meaning stricter monitoring).
Many challenges before 2020
Based on the questions our clients ask us, we noticed that the market is in full preparation for the new Medical Device Regulation. Via Classification Impact Assessments, QbD helps to provide direction. The new portfolio is investigated, the classification is performed and insight is provided in the expected measures the client will have to take.
Enforcement of the European Union’s new UDI is a significant challenge for manufacturers when it comes to the many technical, administrative and operational aspects. At the same time, market players that understand how important it is to be compliant with the regulation at an early stage, will likely profit from the benefits of improved supply management and better management of undesirable situations. In addition, it offers more possibilities for reducing healthcare fraud and it creates transparency throughout the supply chain.
Reduced patient risk
Vision-wise, the regulation is well thought out: a more risk based angle departing from the broader and stricter classification, reduces patient risk. However, implementation-wise, there is a lot of work to do, and all parties lack sufficient resources. Knowledge sharing and flexible use of this knowledge is primordial and will be absolutely necessary in order to conform by 2020.
The new Medical Device Regulation has many similarities to the existing GMP regulation, although we need to keep in mind certain important nuances. And all stakeholders would do well to prepare for the implementation of it. QbD would be happy to guide the entire process.