Change is inevitable, but it’s not always easy. Sometimes, it can be downright difficult. And for many medical device manufacturers, what used to be a seamless process just got a whole lot more challenging, thanks to EU MDR changes.
The European Medical Device Regulation (EU MDR) is a replacement set of standards for medical device manufacturers. The EU MDR changes are not radically different from the previous Medical Device Directive, or MDD. Most of the MDR changes are simply extensions to already existing standards. In most cases, the new requirements bring the EU regulations up to date with the regulatory standards of medical devices that the rest of the world complies with.
But for the manufacturer who wants to continue to supply approved medical devices to the EU market beyond May 2021, complying with the EU MDR changes will require a lot of additional work.
The following are some minor MDR changes:
- Classification Rules: In order for a medical device to be approved, it must fit under one of the three classes of devices: FDA Class I, II, or III. Essentially, most of the same rules still apply but with some new additions, mostly related to software and substances.
- Essential Requirements: This is renamed General Requirements and includes extended requirements.
- Conformity Assessment: The same concepts are retained, which allows manufacturers to choose between different routes, although there is one less route option compared to the MDD.
- Registration: Manufacturing registration requirements remain unchanged. However, manufacturers will need to provide much more in-depth information regarding their devices.
- Notified Bodies: The concept of notified bodies acting as delegates of health authorities and performing premarket assessments and routine audits remains the same, but notified bodies will be under stricter supervision.
So what’re the major EU MDR changes? Below are some significant adjustments:
- Post Market Surveillance: Notified bodies will play a larger role in supervising the manufacturer’s PMS system. Under this requirement, the EU MDR changes also introduce a requirement to produce a PMS report or, depending on the device class, a Periodic Safety Update Report, or PSUR.
- Unique Device Identification: Labeling a device with a UDI is nothing new in the United States, but this is a new standard in Europe.
- Economic Operators: The MDR changes reflect that importers and distributors will also be included and given a set of requirements.
Now for the final two new EU MDR changes:
- One person in the organization must be formally assigned the responsibility of ensuring the regulatory compliance of the enterprise.
- The scope of medical device regulations has extended to products without an intended medical purpose. Products under this umbrella include devices related to a medical purpose, such as colored non-corrective contact lenses.
The objective of the EU MDR changes is to make the regulations simpler and easier to understand. However, the new standards have made things a little more complex. For example, some of the notified bodies’ responsibilities are now requirements that the manufacturer, distributor, or importer must meet, making it that much more difficult to comply with the new MDR changes.
On the other hand, the new standards are also making it difficult for companies to become certified bodies. Because the process is challenging, the number of potential certified bodies has decreased significantly.
The new EU MDR changes have also made it difficult for manufacturers’ medical devices to even be approved to sell to the EU market. Currently, only nine companies have been cleared and approved, based on the new regulations. Previously, dozens of other companies were in the process of complying with the new guidelines, but some well-known businesses have discontinued their efforts because of the high standards.
The new regulation was published in the Official Journal of the European Way in May 2017 and was “entered into force” 20 days later. Even though the new regulation has been entered into force, this does not mean it’s currently in effect. The MDD to MDR transition timeline could potentially end as far into the future as May 27, 2025.
Below is a list of important dates to remember regarding the new EU MDR changes:
- May 2017: Entry into force
- March 26, 2021: Earliest date the new MDR changes can go live
- May 26, 2021: Application date of the EU MDR
- May 26, 2024: Last day to place devices on the market, according to MDD
- May 26, 2025: Last day to put devices into service, according to MDD
If you have questions regarding this new, complex standard, don’t hesitate to contact us! It can be a daunting process, but we’ll walk you through the specifics.
For more information on how to begin complying with the new EU MDR changes, visit the European Union’s official site.