By Mauricio Rodriguez, July 16, 2020

In mid-2020 new European Union MDR regulations were set to go into effect, replacing those that were set back in 2017. Due to COVID-19, this has been delayed by the European Commission, making them effective May 26^th, 2021. However, it is never too early to start adapting to the EU MDR regulatory changes.

With these changes come a lot of questions and concerns from medical device manufacturers who want to make sure that they are compliant with these new rules and regulations. There is much to think about and consider when it comes to the changes in the EU MDR for 2020.

By learning a bit more about these newly updated regulations, you can be sure that you are taking steps to be compliant with these new standards set forth by the European Union. You can also begin to see how working with a medical device regulatory consultant firm will be best suited to help you navigate these new regulatory waters.

What Is the Main Purpose of the EU MDR Changes?

The main focuses of the EU MDR regulatory changes are safety and traceability. The idea is to be able to trace back issues that may occur to find the source of the problem. And safety, of course, is always a key point of concern in regulatory changes and updates.

The EU is essentially trying to be able to better manage medical devices in the EU and ensure that they are as safe as possible for use with patients. These EU MDR changes apply to medical devices and in vitro diagnostic medical devices.

What Is Required from the New EU MDR?

UID

The guidelines for safety with the new EU MDR are much stricter than they were in the past. One major change in the process of getting medical devices okayed for use in the EU is that each device must have a unique device identification code (UDI).

This is a part of the traceability goal of the new EU MDR in that the device can be traced back to manufacturing, even down to a specific date in which it was manufactured.  The UDI also allows the EU to track medical devices and use more easily in general.

Going one step further, devices that are Class IIa/b and Class III will be registered with their UDI to a central EU database known as the European Database for Medical Devices (EUDAMED). Those companies that manufacture Class I devices are not entirely off the hook, though. They will also have to have product data saved in case it is requested at some point, but these products will not be listed in the database.

In essence, the manufacturers of any medical devices for use in the EU will need to update their technologies and put systems into place that allow for the collection and saving of product data for each individual product produced. This information needs to be readily available and accessible to be shared with EU regulatory boards at any given time.

Longer Conformity Assessments

The EU MDR also involves longer conformity assessments for medical devices being utilized in the EU. All currently approved medical devices will need to be reevaluated under the new EU MDR.

Updated Classification Rules

The classification rules for medical devices will also change under the EU MDR. This means that manufacturers will need to reassess their device classifications for every device manufactured for use in the EU. These new classifications are based on risk of use, invasiveness, and other factors.

Wider Product Scope

Many products not previous classified as medical devices under the regulatory codes will now be considered medical devices. An example of this is color contacts, which are largely a cosmetic product. However, they will now be subject to the same regulatory considerations under the EU MDR as other medical devices.

The strengthening of post-market surveillance and Clinical Evaluation requirements for manufacturers

PMS represents one of the focus areas of the MDR regulation, manufacturers will have to implement more stringent PMS procedures that include plans that will need to be maintained, executed and updated throughout the device’s lifecycle and proactive requirements that will include conducting Post Market Clinical Follow Up Studies (PMCF) as well as adding greater emphasis on providing “sufficient clinical evidence” in order to meet the expectations of the notified bodies.

Given all of these changes (and more) under the EU MDR, the assistance of seasoned Quality and Regulatory professionals can help you navigate these uncharted waters. We will help to ensure that you meet all EU MDR regulations and have a smooth transition under these new manufacturing requirements..