Is your medical device compliant with the EU’s Medical Device Regulation (MDR)? According to European Commission’s Medical Device Coordination Group, there are more than 24,000 medical devices under the Medical Device Directive (MDD) that need to be transitioned to MDR. Only 13,000 devices have been submitted by manufacturers for certification to MDR, and merely 3,900 certificates have been distributed through June 2023. NAMSA’s team of medical device regulatory consultants, made up of former Notified Body staff and experts, have identified five reasons why manufacturers should not delay their MDR remediation and certification activities.

Although there are now more than 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.
 


 

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.
 


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 Official 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.
 


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.
 


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.

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Reserve your complimentary consultation to learn how NAMSA’s dedicated team of regulatory and clinical specialists, comprised of former Notified Body staff and experts, can help you navigate the regulatory hurdles faced throughout the transition process and achieve MDR compliance and certification. Fill out the form below and we'll be in touch shortly.