MDR Effects on Business: Case of Dental Units

MDR (Medical Device Regulation)

MDR (Medical Device Regulation) replaced the MDD (Medical Device Directive) because the European Union aimed to improve the safety, effectiveness, and market transparency of medical devices.

The MDR (Medical Device Regulation) came into effect on May 26, 2021, after which all new or updated products must be brought to market in accordance with the MDR 2017/245 EU regulation. Changes to products that were previously under the MDD (Medical Device Directive) can be made, for example, when a component’s manufacture has been discontinued or when something affecting patient safety is being corrected.

What can be done under the MD Directive?

Devices can only be modified in the few exceptional cases mentioned earlier, if they have not been approved under the MDR. New features cannot be added to devices under the MDD.

The product development of both old and new devices is, of course, allowed and essential for the continuity of business. New devices can be “marketed,” brochures and user manuals can be created, but they cannot be SOLD to customers until the Notified Body has approved the product under the MDR regulation.

We are talking about at least Class IIa devices, although the same rules also apply to Class I devices. It’s hard to imagine what a customer might think about a product presented at a major trade show, only to find out that it’s still at the “prototype stage” and cannot be legally purchased. The situation becomes even more interesting when the question is raised: “When can it be purchased?”

As someone familiar with the MDR process, I can say that there is likely no exact answer. One failed EMC test or a risk in fire safety, and back to the drawing board it goes. Money is burned, and a lot of it.

Obtaining an MDR certificate is a selling point that can only be granted by a Notified Body. It can objectively assure customers that the company is a leader in the field and is familiar with the standards and regulations for medical devices in the market, as well as the patient and user safety requirements under the MDR.

Therefore, it may be tempting to present a different picture than what the reality is.

EUDAMED database

The EUDAMED database is a central platform where the status of manufacturers under the MDD or MDR can be checked, provided the information has been registered there. It’s important to note that once MDR product approval is achieved, all related documents are thoroughly available in the database. And why not? It serves as marketing and visibility for the product. Currently, data entry into EUDAMED is not mandatory, so it is easy to reference this when needed.

It’s interesting to follow companies and their websites, especially when their information in EUDAMED is quite limited. They might still boast about new products and features of their devices. Wait a minute… What exactly is a “new feature” that was brought to market 4 years ago? Or is this a case of operating in a very gray area?

Someone is ultimately responsible for this. In the first instance, the person whose name is on the Declaration of Conformity bears the responsibility, especially if patient or user safety is jeopardized. In the second wave, the consequences are felt by customers, company employees, and even the unaware owners of the company. In the worst-case scenario, this can lead to a sales ban imposed by authorities and a recall of products from the market. In the most severe cases, it could result in bankruptcy or legal disputes over liabilities.

What does this mean for products under the MDD?

They can be sold and delivered. Yes, if no changes have been made to them in the last four years. But when looking at, for example, software development and new user interfaces for dental units operating on tablets, they do not appear outdated – on the contrary, new features are continuously being developed and added.

New technical details have been added to devices that visibly affect EMC or, for example, fire safety. However, information about these issues is not actively communicated to the Notified Body. Perhaps it’s assumed that obtaining the MDR certification later will fix these issues.

For new devices, this may be addressed if approval is obtained, but before that, it requires extensive expertise, a huge amount of documentation, laboratory tests, and user testing. If it were easy, everyone would have had the MDR by May 26, 2021.

There are always loopholes in things.

A completely stripped-down basic model can be approved under the MDR without any special features. This moves the process forward, but it won’t be sufficient for customers. This can be done by, for example, limiting the serial number range for different versions of the model. Any products with additional features still fall under the MDD.

The customer may be confused about whether the product is approved under the MDD or MDR, and there’s nothing wrong with that if they can verify which legislation the product falls under.

However, it is wrong if the product is delivered under the MDR but includes features that fall under the MD Directive. This approach presents the same risks as I previously mentioned. It is certainly objectionable to claim to be a pioneer while ultimately exploiting a gray area, potentially to the detriment of the customer.

https://www.fimet.fi/mdr-medical-device-regulations-what-should-the-customer-know