The amendment was necessary due to the continual advancements in technology and development of international initiatives. The Commission was made to constantly analyze the directives in order to ensure the protection of the patients. This amendment also clarified which products were considered medical devices. Currently medical devices under this directive are defined as any instrument, apparatus, appliance, software, material or other article intended by the manufacturer to be used for human beings in the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
- investigation, replacement or modification of the anatomy or of a physiological process control of conception and which does achieve its principal intended action by pharmacological process, immunological or metabolic means but may be assisted in its function by such means
Together with DQS Medizinprodukte GmbH (DQS Inc.’s holding), is now preparing for the MDR transition. The new European MDR originally began a 3-year transition period in May 2017 (5 years for IVD).
For current customer communication regarding MDR/MDD status, please see attached letter here.
Europe’s new Medical Device Regulation (MDR) will bring substantial changes to the way medical device manufacturers bring their devices to the European market, and how they maintain compliance throughout the product’s life cycle.
- Corrigendum to Regulation (EU) 2017/745 of the European Parliament
- MDD Implementation Q&A
- Information to provide in a technical documentation submission
- Implementation Taskforce Roadmap
- DQS Med Information
Please contact DQS Inc. for more information and how we can assist your organization.
If you want to be contacted when we obtain Notified Body designation for MDR, please fill out the below