A new era begins: MDR (Medical Device Regulation) from 26 May 2021
Until May 25, 2021, medical devices were approved and placed on the market in Europe according to the regulations and laws based on the "Medical Devices Directive (MDD)". After 28 years of application, the "Guideline" was replaced by the "Ordinance for Medical Devices (MDR)" on May 26, 2021.
One trigger that led to this change was the scandal surrounding breast implants by French manufacturer PIP, which used industrial rather than medical grade silicone in the implants, causing harm to many patients.
The declared goal of the MDR is to make medical devices safer through stricter regulations.
Ondal has been dealing with the MDR since 2017 and has worked out what is needed to meet all the requirements of the new MDR on May 26th, 2021. For example, the following had to be adapted and revised:
- Technical documentation: Regulatory Affairs created or adapted approximately 1800 documents (development, production, quality and regulatory documents) in collaboration with Product Data Management and the Development Department.
- Instructions for use: The team from the Product Data Management department recreated all instructions for use and had them translated into all relevant national languages. In parallel, the assembly and service instructions and the supplementary sheets were converted from an enclosed paper version to electronic data for downloading. To make this possible, a new online portal was introduced with the IT department. Subsequently, the corresponding parts lists were adapted in cooperation between Product Data Management, Development and Industrial Engineering. The changeover results in cost savings and the conservation of resources through less paper consumption.
CE declarations of all products: these were revised in terms of content by Regulartory Affairs and re-signed by the management.
Clinical evaluations (compilation and assessment of market experience with our and similar devices): these must now cover every product and have been redone by Regulatory Affairs. - Nameplates and labels: a mark identifying the product as a medical device must now be included. Therefore, all type plates and labels have been adapted to the new requirements by the Product Data Management departments.
After a transition period until 2023, the requirements of the MDR for a unique identification of medical devices by a unique number (UDI) have to be fulfilled. Ondal is a member of GS1, a company accredited to issue UDIs, and has reserved unique numbers for use. The next step is for the Product Data Management department to adapt the nameplates and labels so that the UDI numbers can be read there electronically.