Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) introduce numerous new requirements for manufacturers, importers, and distributors of medical devices. However, it is crucial not to forget the obligations imposed by other applicable regulations, such as the REACH Regulation (EC) No. 1907/2006.
Before medical devices can be placed on the market in the European Union, they must be registered.
While EUDAMED (European Database on Medical Devices) is not yet fully functional, transitional regulations apply, specific to each country. In Germany, these regulations are outlined in announcements from the Federal Ministry of Health (BMG) regarding the transitional period until the full functionality of EUDAMED (Federal Gazette AT 28.05.2021 B6 and AT 27.05.2022 B4).
It is no longer new that Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) impose certain requirements on importers and distributors of medical devices. These requirements are described in detail in:
Starting from August 31, 2023, reports of adverse events related to medical devices that have occurred in the United Kingdom (UK) can only be submitted through the national MORE-Portal (Manufacturer Online Reporting) of the Medicines & Healthcare products Regulatory Agency (MHRA).
As of December 01, 2020 the European Commission will make the Actor registration module available which will be the first of six EUDAMED modules.
Together we bring your medical products to the world market, meet international regulations and guarantee product quality and safety.
The introduction of a quality management system according to EN ISO 13485 often marks the beginning of the world of the medical device industry.
The approval of medical devices is a complex subject that covers a multitude of areas and poses a challenge for those placing medical devices on the market.
The clinical Evaluation is an essential part of the technical documentation and a prerequisite for the fulfilment of the Essential Requirements.
Each medical device or IVD manufacturer and authorized representative must designate responsible person(s) (PRRC - Person Responsible for Regulatory Compliance).
