MDD Declaration of Conformity After 26 May 2021

As a regulatory representative for foreign manufacturers in the EU, UK, US, and Switzerland, MedEnvoy participated in several audits with different national competent authorities. During these audits, we had the chance to collaborate with competent authorities to continuously ensure product safety and efficacy.

MDD declaration of conformity updates for legacy devices

Recently, Economic Operators in Switzerland faced scrutiny from the Swiss Competent Authority (Swissmedic), with Swissmedic conducting audits on Swiss manufacturers, Swiss Authorized Representatives, and Swiss Importers. As a regulatory in-country representative, and regulatory importer in Switzerland, MedEnvoy has participated in some of these audits and has noticed a focus on updates to Declarations of Conformity (DoC) for legacy devices after 26, May 2021.

Issuing a new declaration of conformity in accordance with MDD

Legacy devices, as defined by Article 101 of the Medical Devices Ordinance (MedDO) and Article 120 (3) of the Medical Device Regulation (MDR) that intended to benefit from the transitional provisions amended by Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 regarding certain medical devices and in vitro diagnostic medical devices must have a Declaration of Conformity (DoC) that was drawn up before the date of application of the MDR, (i.e. May 26, 2021). Therefore, issuing a new Declaration of Conformity, including amended, adapted, or supplemented DoCs in accordance with MDD, is not allowed after the date of application of the MDR, as emphasized by Swissmedic in its Frequently Asked Questions on Medical Devices official website1and during the audits we attended.

Recommendations and next steps

We understand that Regulation (EU) 2023/607 introduces longer timelines for legacy devices, which may have an impact on the information included in the Declaration of Conformity issued before May 26, 2021, requiring updates to be accordingly identified. However, manufacturers should only update a Declaration of Conformity of a legacy device under specific circumstances, such as a grammatical error/typos, a change in the manufacturer’s name approved by the Notified Body, or a change in their European Authorized Representative (please note, this list of examples is not exhaustive). In such cases, MedEnvoy strongly recommends that an addendum to the Declaration of Conformity of the legacy device in question is created, with an explanatory note describing the reason for the update, and a clear identification of the changes implemented. In addition, it is advised that this explanatory note indicates that no significant changes to the product were implemented, and no new products were added to the Declaration of Conformity concerned. Therefore, the original Declaration of Conformity signed before May 26, 2021, should not be altered in any way and, as such, shall be considered the primary Declaration of Conformity in which compliance with Directives 93/42/EEC or 90/385/EEC is declared. It should be noted that also in such cases manufacturers should maintain a revision history within their quality management system, outlining which changes were made and when, along with a statement that the change is not significant. By following these best practices, manufacturers can ensure compliance with regulatory requirements and avoid penalties or other adverse consequences.

Learn more about regulatory compliance with MedEnvoy

If you have any additional questions regarding legacy devices or information on the MDD declaration of conformity adjustments get in touch.