The MDR deadline for Manufacturers of risk class I products is approaching. The days until May 26, 2020 are numbered!
It is fundamental that class I Manufacturers prioritize their MDR compliance in order to ensure a smooth transition to the MDR and avoid any market disruption by May 2020.
The transition period has started in 2017. Manufacturers must update the declaration of conformity to reflect the compliance to the MDR. This does not include only an update of the technical documentation but also the requirements of Article 10 to meet the new MDR requirements.
CONTACT NOW your MDSS team to get your products ready to market by May 2020!!!
The existing MDD Authorized Representative contract will no longer be sufficient for the transition to the new regulation. The appointment of the Authorized Representative under the MDR is a mandatory requirement to achieve compliance by May 26, 2020. In order to act as your EC REP, the regulation requires that the Manufacturer provides an official Mandate to the EC REP. Such a mandate shall be in writing and agreed by the EC REP. The mandate shall contain a minimum set of tasks. The new MDSS MDR EC REP contract is the basis for such a mandate. Clients should submit their MDR transition plans and consider MDSS resources to perform the tasks required under the MDR mandate.
MDSS has implemented a special plan for its clients. Any remuneration fees still not used on the MDD contract will apply to the MDR Mandate.
Please contact your Account Administrator at MDSS!