Dear valued customer,
As you are no doubt aware the EU MDR Regulation (EU) 2017/745 The European Union Medical Device Regulation of 2017 comes into force on 26th May 2021.
Timesco are well prepared for this and we are pleased to announce that we have appointed MedEnvoy, based in the Netherlands, to act as our MDR Importer. Our EC REP, Advena Ltd based in Malta, are updating the registration of our single use Laryngoscopes from the MDD, Medical Device Directive 93/42/EEC, to the MDR with the Maltese competent authority, Malta Medicines Authority. When this registration is complete we will place our single use Laryngoscopes on the market in accordance with the MDR.
Timesco’s reusable devices, including Laryngoscopes, Diagnostic Sets and Surgical Instruments, will continue to be placed on the market under the MDD for the foreseeable future, permitted by MDR Corrigendum 2, as these devices are being up classified from class 1 to class 1r and will require Notified Body involvement. We are working closely with our Notified Body (SGS Belgium) on this project and aim to complete our formal MDR application for these devices prior to April 2023 which is when our MDD Annex V certificate expires.
Please do not hesitate to contact me if you have any questions.
Quality & Regulatory Affairs Manager