July 20, 2023
The recent amendment of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) through Regulation (EU) 2023/607 has introduced crucial changes to safeguard public health, prioritize patient safety, and prevent disruptions in healthcare services. The Q&A document regarding the extension of the MDR transition period and removal of the “sell-off” periods has been updated (July 2023) in response.
Key Changes to the Q&A Document on the MDR Transition Period
MDx CRO had previously published a comprehensive summary of the European Commission’s Q&A document.
The following questions in the Q&A document have undergone significant changes:
- Q&A no 1: The Commission will provide flowcharts to assist manufacturers and other relevant parties in determining whether a device falls under the extended transitional period specified in Article 120 MDR.
- Q&A no 2: Clarifies that a letter from a notified body regarding the certificate’s expiry or a controlled phase-out of production, mutually agreed upon by the notified body and the manufacturer before 20 March 2023, is not considered a certificate withdrawal.
- Q&A no 7: Manufacturers need to provide a self-declaration confirming their compliance with the extension conditions and stating the end date of the transition period. They can include a “confirmation letter” from the notified body, which identifies the devices and certificates covered. Templates for the self-declaration and notified body’s confirmation letter are available at this link. Furthermore, an updated factsheet for competent authorities in non-EU/EEA countries explains the functioning of the extended transition period.
- Q&A no 8: Clarifies that that when submitting information, notified bodies (as per Article 36(2) MDR) must have the capability to include the relevant (digital) document(s) in their own records. Simply having ‘read-only’ access to the manufacturer’s electronic data platform is not considered sufficient.
- Q&A no 17: Manufacturers must inform the notified body about devices that require surveillance, especially if surveillance activities were discontinued due to certificate expiration before 20 March 2023. This information allows the notified body to conduct proper surveillance and make necessary arrangements with the manufacturer.
New Additions to the Q&A Document
The following questions have been newly introduced in the MDR Transition Period Q&A document:
- Q&A no 6.1: If a competent authority grants a national derogation under Article 59 MDR or requires a manufacturer to follow the applicable conformity assessment procedure as per Article 97 MDR after 20 March 2023, the extended transitional period specified in Article 120(3a) MDR does not apply.
- Q&A no 6.2: If the removal of the CE marking is a condition or consequence of the derogation granted by the competent national authority according to Article 59 of the MDR, the device may still be placed on the market with a CE marking, provided that all other conditions are met.
- Q&A no 9.1: If a manufacturer withdraws the conformity assessment application or terminates the written agreement with the notified body after the deadlines, the extended transitional period ends. However, if the manufacturer switches to another notified body and fulfills all conditions, the transitional period continues. Updated documentation is necessary after the change, except when changing notified bodies due to non-compliance.
- Q&A no 9.2: The manufacturer’s organization may undergo administrative changes, such as changes in name, address, or legal form, which generally do not impact the transitional period during the extended transition period. However, the transfer of devices from a manufacturer certified under MDD/AIMDD to another manufacturer intending to market them under MDR is not covered by the transitional period, unless both manufacturers are part of the same larger organization.
- Q&A no 11.1: Legacy devices are not required to comply with the Unique Device Identification (UDI) requirements of the MDR during the extended transitional period. Even after May 26, 2024, when the manufacturer of the legacy device must have an MDR-compliant Quality Management System (QMS), UDI requirements will only apply if UDI assignment is necessary for those devices according to Article 10(9), point (h), of the MDR.
MDR Transition with MDx CRO
In conclusion, these recent changes and additions to the medical device regulations are significant milestones that harmonize industry standards and ensure a smooth transition for legacy devices, prioritizing safety and public health. The Q&A document serves as an essential tool for manufacturers, notified bodies, and competent authorities navigating the evolving regulatory landscape within the European Union.
Take advantage of MDx CRO’s expertise to ensure MDR compliance and meet transitional period requirements. Partnering with MDx CRO empowers manufacturers to meet safety standards, unlock opportunities in the European healthcare market, and contribute to healthcare advancements. Contact us today!
