for Manufacturers OF
The new Medical Devices Regulation (2017/745/EU) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) bring EU legislation in line with technical advances, changes in medical sciences and progress in regulatory areas.
The new Regulations create a robust, transparent and sustainable regulatory framework that is internationally recognized, will improve clinical safety and create equal market access for manufacturers.
Unlike the Directives, the Regulations are not subject to implementation into national legislation. Thus, MDR and IVDR will reduce the risks of interpretation discrepancies in the EU market
Transitional periods are provided for the smooth application of the new Regulations. However, you should keep in mind that as the deadline approaches, consultants, local specialists and notified bodies will be busier.
The MDR will replace the current Medical Devices Directive (93/42/EEC) (MDD) and Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).
The MDR was published in May 2017, marking the start of a four-year transition period from MDD and AIMDD.
During the transitional period, the MDR will come into effect in stages, starting with provisions related to the appointment of notified bodies and the acquisition of new certificates by manufacturers under the MDR Regulation..
The transition period will end on May 26, 2021, which is the effective date (DDA) of the Regulation.
From that date, the MDR Regulation will apply in full.
Who is responsible for the compliance of the manufacturer and his products with the requirements of the EU regulation
Clinical evaluation and PMCF