Five Reasons Not to Delay Your MDR Certification

The transition from the old Medical Device Directives (MDD) 93/42/EEC and 90/385/EEC to the new Medical Device Regulation (MDR) EU 2017/745 has not run smoothly. Manufacturers continue to navigate the bumpy road to MDR compliance for their legacy devices. Many factors have contributed to the slow progress, including a lack of Notified Body capacity, the manufacturer’s reluctance to understand and invest in MDR compliance and the slow introduction of guidance and Common Specifications, to name but a few.

The MDR entered into force on 25 May 2017, with 26 May 2020 as the date of application. Many manufacturers took the opportunity to renew their existing MDD certificates, which meant they did not have to comply with the MDR until 26 May 2024. However, the EU Commission took several emergency measures because of delays in MDR certification and fear that manufacturers would lose EU market access, denying patients essential medical devices. The measures taken included extending the date of application until 26 May 2021 and allowing MDD certificates to remain valid, under certain conditions, until 31 December 2027 (Class III and Class IIb implantables) and 31 December 2028 (Class IIb non-implantable, Class IIa, Class I sterile and Class I measuring).

The transition period extension is a welcome relief for manufacturers developers and Notified Bodies. However, many manufacturers  have used it to delay their MDR remediation activities without considering their business’s short- to medium-term impact. Notified Bodies have reported a significant downturn in MDR applications and remain concerned that manufacturers may not understand the implications of their delays.

NAMSA has identified five reasons manufacturers should not delay their MDR remediation and certification activities:

 

#1 Notified Body Pressure

Although there are now forty Notified Bodies designated under the MDR, many have a limited scope to their designation, i.e., they cannot certify all device types. Furthermore, each Notified Body only has a finite number of resources and will deploy them on a first-come, first-serve basis. If manufacturers delay their applications, creating a peak demand as the deadlines approach, the Notified Bodies will not be able to process all applications in time.

In the recent EU Notified Bodies Survey on Certifications and Applications (MDR/IVDR), 25 October 2023:

• 45% of Notified Bodies indicated they have a 6 to 12 months lead time to issue an MDR Quality Management System (QMS) certificate.
• 40% of Notified Bodies indicated they have a 13 to 18 months lead time to issue MDR QMS and Product Certificates.

The lead times are likely to worsen as the new deadlines approach. Manufacturers should not delay their MDR applications if they hope to have certification by the new deadlines.

Manufacturers should note that under (EU) 2023/607, to take advantage of the extension to the transition deadlines, they must have an MDR-compliant QMS and lodge a formal application with a Notified Body by no later than 26 May 2024, and have a signed written agreement with the Notified Body for the MDR conformity assessment by 26 September 2024.

Have you submitted your MDR application?

#2 Limitations on Manufacturers

Article 120 of the MDR restricts the manufacturer’s ability to make significant changes to devices certified under the MDD. Legacy devices become effectively frozen in time, restricting the manufacturer’s ability to advance their products and introduce new features and functions to the EU market. Manufacturers cannot make significant changes to legacy devices certified under the MDD, including:

• Extension of the intended purpose, e.g., new indications for use, new users or patient populations.
• Changes to the design that alter the operating principles of the device.
• Changes to the materials of an implant or changes affecting animal/human tissues or medicinal substances.
• Changes to the sterilization method.

MDCG 2020-3 provides full details of the changes allowable under Article 120.

Manufacturers with MDR certification have control over the changes they wish to introduce. They can plan product enhancements and new variants to meet patient and user needs, giving them a competitive advantage over manufacturers that don’t have MDR certification. Effectively, once a manufacturer has gained MDR certification for their devices, it is business as usual, and development plans can progress unhindered.

Do you need to make significant changes to your device?

#3 EUDAMED UDI Deadlines

The European Database on Medical Devices (EUDAMED) and Unique Device Identification (UDI) system compliance deadlines have not changed and must still be met to place products in the EU market. Manufacturers are required to display UDI carries on labels as follows:

• Class III and implantable devices from 26 May 2021
• Class IIb and Class III devices from 26 May 2023
• Class I devices from 26 May 2025

Similarly, direct marking of reusable devices is required as follows:

• Class III and implantable devices from 26 May 2023
• Class IIb and Class III devices from 26 May 2025
• Class I devices from 26 May 2027

EUDAMED becomes mandatory six months after publication in the Journal, expected in quarter four of 2024. Actor registration and UDI/Device Registration can be completed now, so there is no need to wait for the mandatory deadline.

Have you implemented the UDI requirements?

#4 Non-EU Registration Considerations

Manufacturers use CE certification to support device registration in markets outside the EU. These jurisdictions currently accept MDD certification. However, it is unclear in many jurisdictions how these requirements will change in recognition of MDR requirements and deadlines. Manufacturers may have decided to delay MDR certification so that other jurisdictions are not impacted. Unfortunately, this delay will only push the problem further down the road and may compromise CE certification and other market access. It is, however, possible to hold simultaneous MDD and MDR certifications, mitigating those concerns. The sooner the manufacturer completes MDR certification, the sooner they can focus on supporting registrations in other jurisdictions.

Do you understand how changes under the MDR will impact worldwide market access?

#5 Competitive Advantage

Compliance with the latest EU legislation provides the manufacturer credibility as it demonstrates that their devices comply with the latest performance and safety requirements. Healthcare providers will likely favor devices from manufacturers compliant with current legislation over those not, particularly when considering tenders for large orders.

Manufacturers compliant with the MDR are not limited in the design changes they can make. Therefore, they can respond quickly to new and enhanced functionality requests.

The manufacturer’s regulatory team cannot successfully transition devices from the MDD to the MDR without support from other functional teams, including the products experts such as engineering and clinical. When these teams try to develop the next generation of products but have to support regulatory activities, this will significantly delay new product introductions.

Manufacturers who fail to meet the MDR transition deadlines will be forced to remove their devices from the EU market, sacrificing market share to their competitors.

Do you have the resources available to support your MDR transition?

How Can NAMSA Help?

The MDR continues to bring manufacturers many challenges that the deadline extension has not eased. NAMSA has a dedicated team of regulatory and clinical specialists, comprising of former Notified Body staff and experts, to help you successfully achieve MDR compliance and certification. To learn about NAMSA’s full suite of Regulatory services and solutions, including MDR compliance planning, please visit: https://namsa.com/services/regulatory-and-quality-consulting/.

If you are interested in scheduling a complimentary consultation with one of our EU MDR experts, we invite you to do so at https://namsa.com/locations-contact/.