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Switzerland : European Medical Devices Regulation (Mdr) 2017/745 Update.

The new European Medical Devices Regulation (MDR) EU 2017/745 will legally apply from May 26, 2020, and SGS, like all other Notified Bodies, will no longer be authorized to deliver CE certificates under the Medical Devices Directive (MDD).

As a result, SGS will guide its customers through the process of transferring their certificates from MDD 93/42/EEC to the new regulation. However, we will continue to support existing MDD certification until the end of their validity period or May 25, 2024, at the latest through specific MDD surveillance audits.

Mdd Recertification Requests: In the coming months, as medical device manufacturers prepare their transition to the new regulations, some may request early MDD recertification audits to extend the validity of their CE certificates. However, rather than an additional interim MDD recertification audit, it is more effective for you as an SGS client to maintain your current MDD certification cycle, allowing maximum time to prepare for the transition. You should then progress to a new initial MDR assessment as soon as you are ready.

During the transition overlap period, SGS will need to support both the existing MDD and the new MDR. As a result, we will not be in a position to provide early recertification, except in exceptional circumstances. To meet the challenges of the transition period, it is likely that the majority of Notified Bodies will follow this approach.

For exceptional circumstances, where earlier recertification is required, your SGS Delivering Office must contact the Notified Body to discuss possible options. Earlier recertification will seriously impact the resources of both the Notified Body and the medical manufacturer. As a result, it should only be considered as a last option for specific cases.

SGS is currently undergoing the MDR Notified Body (NB) designation process. It is expected that this process will be complete by the end of 2019. Once we are designated as an MDR NB, we will be authorized to conduct MDR certification audits and technical documentation reviews. We will also continue MDD audits and technical file reviews until November 30, 2019.

After this date, no new MDD activity, such as certification or extension to scope, will be conducted. This will allow adequate time for finalizing activities, including CAR closing and certification review, as we move towards the final deadline for MDD on May 25, 2020.

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Publication:Mena Report
Date:Feb 4, 2019
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