The MDR represents a high workload for manufacturers of medical devices.
For example, the requirements for the content of technical documentation are regulated in significantly more detail. All products must have a unique product identification number (UDI).
The previous PLM/OEM business models are no longer accepted by the notified bodies.
The EUDAMED (European Databank on Medical Devices) database has been extended and made publicly accessible.
This database stores data concerning products (registration), product identification (UDI), economic operators (manufacturers, distributors, importers, authorised representatives), adverse events (vigilance), clinical trials, certificates, etc.
Implementation of the MDR by the date on which it comes into force on 26 May 2020 poses significant challenges for manufacturers of medical devices.
KOB is preparing intensively for this.
Overview of the primary requirements of the MDR*
Classification of some products:
Manufacturers must review the previous classification according to the new regulation and update it if necessary. Reclassifications and higher classifications will be required.
Manufacturers must revise the evidence of their compliance with the essential requirements of the Medical Device Regulation (MDR). The requirements outlined in Annex I have been fundamentally revised and now include essential safety and performance requirements. Manufacturers must demonstrate their compliance with the revised annex.
Content of technical documentation:
All manufacturers are obliged to maintain technical documentation. Manufacturers must review all previous technical documentation in accordance with the Medical Device Regulation (MDR) and update it if necessary. The content of the technical documentation is now described in the new annexes II and IIa.
Importance of clinical data and evaluation by competent individuals:
Manufacturers may need to reperform clinical evaluations. Competent employees must be hired for this or found as external employees.
The content and structures of the EUDAMED database are significantly larger, so there will be central manufacturer and product registrations in the future, according to the Medical Device Regulation (MDR). The EUDAMED database is also used for processing events. The database is populated, and the requested data is then the responsibility of the notified bodies and the authorities, as well as the manufacturers.
Collaboration between manufacturers and representatives, importers and distributors:
Business relationships between importers, distributors, representatives and service providers will be intensified. The requirements according to the Medical Device Regulation (MDR) are increasing, and expanded contract agreements may be required in order to improve communication between the parties involved, for example.
Product identification and traceability:
A product must be labelled with a UDI (unique device identification) code. The EUDAMED database will also play an important role in this. Transparency in the supply chain is a key factor here. In the future, it should be clear how products in Europe are supplied to end customers. Importers and distributors also play an important role in this.
Transparency of outsourced processes in EUDAMED report:
Manufacturers who get their product developed and/or produced by a supplier must record these suppliers in the EUDAMED database.
Post-market surveillance (PMS):
Post-market surveillance (PMS) must be carried out for all medical devices. PMS shall be implemented as part of the quality management system in accordance with the risk class and type of product.
* Source: www.tuev-sued.de/akademie-de/seminare-gesundheitswesen-und-medizintechnik/medizintechnik/medical-device-regulation-mdr