MDR
MDR (EU MDR,WE2017/745)
MDR stands for the Regulation of the European Parliament and of the Council (EU) 2017/745 of 5 April 2017 on medical devices (Medical Devices Regulation).
The Regulation on medical devices EU 2017/745 has been in force since 26 May 2021, simultaneously replacing the previously applicable European Council Directive 93/42/EEC MDD (Medical Device Directive).
The MDR regulation applies in all European Union countries and establishes provisions regarding the placing on the market or putting into service of medical devices for human use, as well as equipment for such devices. It also applies to clinical investigations conducted in the European Union concerning medical devices or their accessories.
The scope of application of the MDR has been significantly expanded compared to the MDD and includes products intended for both medical and non-medical use. The new regulations cover, for example, contact lenses, equipment used in cosmetic clinics, and many others. Many medical devices that previously did not require certification by a Notified Body (Class I medical devices) under the MDD now require such certification under the MDR (as they have changed from Class I to Class IIa).
The MDR aims to establish high-quality and safety standards for medical devices, as well as standardization of the principles for placing them on the market and their use within the European Union.
eCValidation offers comprehensive consulting services in the following areas:
- Development of the required quality documentation necessary for MDR implementation.
- Conducting audits to assess the entity's readiness for MDR implementation
MDR implementation
Our approach begins with collaborative workshops where we gain a deep insight into the organization’s processes. By analyzing current practices, we create a personalized roadmap and scope of work for the successful implementation of MDR.
Throughout the entire implementation process, our team provides continuous support, ensuring that the organization is adequately prepared for audits and certification. We guarantee a positive outcome of the compliance audit.