Dear Madam, Dear Sir,
As already announced, the new EU Regulation on Medical Devices, Medical Device Regulation (MDR), replaces the previous Directive 93/42/EEC Medical Device Direction (MDD) and the 90/385/EEC Active Implantable Medical Devices (AIMD). The following mailing is intended to provide you with brief information on the MDR status and to inform you about further deadlines.
All manufacturers of medical devices from Class I to III must now deal with the new requirements promptly. For the first time, MDR is used to regulate products that are not medical devices in themselves. The changes include the classification of products, technical documentation, market surveillance and the quality management system.
In this context, we would like to take this opportunity to draw attention to upcoming internal deadlines under MDD:
Applications for technical documentation, amendments and re-certification should be submitted by 30.06.2019 at the latest.
If you have already done so, you should have submitted the documents for the technical documents or amendments. Last date for submitting applications is the 31.07.2019.
Re-certification Audits for the MDD can still be carried. Please note that the deadline for re-certification is 31.12.2019.
Please consider the mentioned deadlines for planning the transition from MDD to MDR. In order to continue to actively support you, it would be advantageous if you could provide us with feedback on this and let us know your plans for the transition from MDD to MDR.