In 2010, nearly half a million women discovered they received breast implants that contained industrial-grade silicone not intended for human use.
For almost a decade, women would receive implants manufactured by the French company Poly Implant Prothèse (PIP). The firm was liquidated right after their negligent practices came to light. And the PIP implant was banned.
With PIP silicone implants in their bodies, many women have suffered from prolonged medical issues — including auto-immune diseases and long periods of anxiety.
An investigation into the matter showed that PIP implants were more likely to burst and leak into a woman’s body.
In 2021, the French court decided that women who received the implant should be compensated — at least hundreds of women who had breast augmentation surgery after 2006.
The PIP scandal was a major force that prompted the new health regulations for the European Union.
Up until that point, the EU manufacturers specializing in medical products had to follow the regulations prescribed by the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD).
In 2021, the EU MDR replaced both, introducing a far stricter and more detailed framework for securing medical devices, products, and accessories within the EU market.
What has the introduction of MDR Medical Device Regulations (EU) 2017/745 meant for manufacturers?
Stricter Conditions for Manufacturers
To comply with the new MDR regulation and get the green light for the market, medical manufacturers have to:
- Meet all the safety requirements for the product within a specific classification
- Provide continual clinical evidence and data
- Assign the person for regulatory compliance
- Track the product and continue testing in the post-market stage
If the product falls under the higher risk category, there are stricter rules that the device has to meet to comply with the MDR.
Every manufacturer needs to have a person responsible for regulatory compliance. This is someone well-versed in the latest safety obligations that products need to meet in pre and post-market stages.
Lack of Notified Bodies in EU
Manufacturers are not the only ones that need to meet the requirements of the MDR regulations. Notified bodies also have to be certified or recertified to approve medical products for the market.
To make this even more challenging for manufacturers, the number of notified bodies that have passed the new stricter law and thus can approve the product for the market has been reduced significantly.
Before the regulation, there used to be 90 notified bodies. Now, there are 30 MDR-certified ones that manufacturers can choose from. For manufacturers, this means that they need to wait far longer for their product to get approved and reach the market.
More Products Need to Get Clearance After MDR
EU MDR redefined the medical devices category to cover more devices and products that are used for health purposes. For manufacturers, this means that their product might now be covered by the regulation even though it wasn’t previously.
One example of this is software and applications used for health monitoring, diagnostic aids, or treatment support. They now fall under this broader definition of a medical device.
But even products such as implants or colored contact lenses that don’t fall under the scope of products that are used for medical purposes now have to adhere to MDR regulations.
Then, there are a lot of products that have to be reapproved. They might have been cleared and approved by the preceding directives (MDD and AIMDD).
Regardless, they are denied the mark (e.g. CE-mark) that shows they meet the safety standards. For a manufacturer, this might mean that their product requires more clinical testing and research they have to provide as they reapply for MDR.
For medical manufacturers whose products have been on the market for decades, it can be difficult to provide new data for such long-lasting products.
Added Tracking of Devices and Surveillance
Product makers must adhere to strict regulations even after they release their products. Every device or accessory gets a unique device identifier (UDI). UDI enables tracking of the product within the market.
Information about every product on the EU market is logged in the European Database on Medical Devices (EUDAMED).
The EUDAMED system contains all the important information about medical products within the EU market.
For every device that is registered and part of the database, it’s possible to track the latest:
- Incidents
- Granted certifications
- Clinical testing and investigations
Even after the product is released to the market, manufacturers are obligated to provide this data to ensure complete transparency across the product’s entire lifetime.
This is to make sure that any health risks that might come with the product are discovered early and prevent further damage.
To compare, the Medicines and Healthcare Products Regulatory Authority (MHRA) has been receiving reports about the potential risk of PIP implants since 2002.
Up until the year 2010, they got 269 reports about faulty PIP implants — many describing that the implant ruptured and leaked into women’s bodies.
It was not until eight years after the first reports came to light that unsafe PIP implants were banned.
More Difficult to Release Unsafe Medical Products in the EU
A common remark from manufacturers is that EU MDR is overly restrictive. That it hinders innovation as well as causes major delays.
Before, medical manufacturers could design, test, and get their products to the market faster.
Today, with MDR medical device regulations, European manufacturers, as well as those who want to enter the EU market, face a series of obstacles.
For example, the same product that was cleared by the FDA in the US might not be suitable for EU standards. It’s easier to get it FDA-approved for the US market.
However, this caution is a necessity.
Ultimately, MDR is there to protect patients from negligent practices that put their lives at risk — to prevent incidents such as the PIP scandal.
