Mike Edwards, Director of Product Management, Sparta Systems01.04.19
The upcoming European Union Medical Device Regulation (EU MDR), sets high standards of quality and safety for medical devices produced in or supplied to Europe. It will replace the EU’s current Medical Device Directive (MDD) and the EU’s Directive on active implantable medical devices. As the May 2020 deadline approaches, the medical device industry must prepare for far-reaching changes.
While the EU MDR helps clarify ambiguous elements of the previous MDD, the regulation and its anticipated rollout have generated feelings of uncertainty within the industry. Many manufacturers have specific questions on the scope and definition of the changes.
Here are five questions the medical device industry should be asking right now to prepare for the regulation.
1. What Products Are Included in the Scope of the EU MDR?
There are several new classifications of devices within the scope of the regulation for the first time, such as accessories that assist a device. Others were previously included but are now reclassified into stricter standards or their existing classification structure requires more documentation for a successful approval. Manufacturers will also need to review devices in the field today—there are no grandfathered devices for EU MDR. With estimates of over 500,000 unique devices sold in Europe today, this is a huge undertaking.
2. What Are the Deadlines and When Do We Need to Start Preparing?
The new EU MDR regulations will go into effect on May 26th, 2020 and manufacturers should plan to be compliant by then. However, many organizations could fall behind schedule and risk falling out of compliance. Additionally, we can anticipate increased strain on Notified Bodies, few of whom have been recertified under the new regulation at present. This could significantly delay the approval of medical devices.
3. Who Is In Charge of Ensuring the Organization Is in Compliance with the New EU MDR Regulations?
Industry professionals must ensure they name a person responsible for compliance. If the organization is outside of Europe, a Europe-based Authorized Representative must be named to incur responsibility for compliance and device safety.
Complexities can arise when naming the Authorized Representative. Organizations must find a way to centralize relevant documentation, quality, regulatory, and clinical data to demonstrate an appropriate level of oversight of the manufacturing and distribution of compliant devices.
4. What Are Other Compliance Requirements to Keep in Mind?
There are requirements for conducting clinical investigations and industry professionals believe the requirements will be less specific than ISO 14155 of ICH GCP. However, authorities will judge applications by the higher ISO 14155 of ICH GCP standards when this rolls out. The industry is curious about these standards and what will change here for their preparation.
Some companies have already complied with some of the FDA’s deadlines for a unique device identifier (UDI). For these organizations, it is uncertain if these will be the same when it comes to structure, data, and processes to comply with EU’s UDI requirements. If not, changes will need to be made, and professionals are curious about the best way to go about this.
5. What Are the Most Important Changes to Look Out for?
One key area to keep an eye on are the standards affecting software and devices that were not previously regulated. Organizations also need to take a close look at how existing devices will be classified as well as how existing classification approval requirements will differ.
Data from clinical trials as well as suppliers will be needed to demonstrate devices and accessories meet the new regulatory standards. Companies will need to establish cross-functional teams to fully assess the regulation, ensure alignment, and implement changes.
This all needs to be done and cleared for medical devices and systems by May 2020. It is crucial that organizations make any necessary changes as early as possible to ensure there is enough time to certify affected devices and prevent patients and consumers from being impacted.
While the EU MDR helps clarify ambiguous elements of the previous MDD, the regulation and its anticipated rollout have generated feelings of uncertainty within the industry. Many manufacturers have specific questions on the scope and definition of the changes.
Here are five questions the medical device industry should be asking right now to prepare for the regulation.
1. What Products Are Included in the Scope of the EU MDR?
There are several new classifications of devices within the scope of the regulation for the first time, such as accessories that assist a device. Others were previously included but are now reclassified into stricter standards or their existing classification structure requires more documentation for a successful approval. Manufacturers will also need to review devices in the field today—there are no grandfathered devices for EU MDR. With estimates of over 500,000 unique devices sold in Europe today, this is a huge undertaking.
2. What Are the Deadlines and When Do We Need to Start Preparing?
The new EU MDR regulations will go into effect on May 26th, 2020 and manufacturers should plan to be compliant by then. However, many organizations could fall behind schedule and risk falling out of compliance. Additionally, we can anticipate increased strain on Notified Bodies, few of whom have been recertified under the new regulation at present. This could significantly delay the approval of medical devices.
3. Who Is In Charge of Ensuring the Organization Is in Compliance with the New EU MDR Regulations?
Industry professionals must ensure they name a person responsible for compliance. If the organization is outside of Europe, a Europe-based Authorized Representative must be named to incur responsibility for compliance and device safety.
Complexities can arise when naming the Authorized Representative. Organizations must find a way to centralize relevant documentation, quality, regulatory, and clinical data to demonstrate an appropriate level of oversight of the manufacturing and distribution of compliant devices.
4. What Are Other Compliance Requirements to Keep in Mind?
There are requirements for conducting clinical investigations and industry professionals believe the requirements will be less specific than ISO 14155 of ICH GCP. However, authorities will judge applications by the higher ISO 14155 of ICH GCP standards when this rolls out. The industry is curious about these standards and what will change here for their preparation.
Some companies have already complied with some of the FDA’s deadlines for a unique device identifier (UDI). For these organizations, it is uncertain if these will be the same when it comes to structure, data, and processes to comply with EU’s UDI requirements. If not, changes will need to be made, and professionals are curious about the best way to go about this.
5. What Are the Most Important Changes to Look Out for?
One key area to keep an eye on are the standards affecting software and devices that were not previously regulated. Organizations also need to take a close look at how existing devices will be classified as well as how existing classification approval requirements will differ.
Data from clinical trials as well as suppliers will be needed to demonstrate devices and accessories meet the new regulatory standards. Companies will need to establish cross-functional teams to fully assess the regulation, ensure alignment, and implement changes.
This all needs to be done and cleared for medical devices and systems by May 2020. It is crucial that organizations make any necessary changes as early as possible to ensure there is enough time to certify affected devices and prevent patients and consumers from being impacted.
