It is well known that from 26 May 2017, Medical Device Regulation (MDR) – a new Regulatory framework for medical devices has come into force in the European Union (EU). Similarly, new In Vitro Diagnostic Device Regulation (IVDR) has also been published to regulate in vitro diagnostic devices in the EU. Aiming at better Regulatory base for Medical Devices in the EU market, the new Medical Device Regulation (MDR), a combination of MD Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMD), is being introduced as a Regulation instead of Directive.
The MDR - Transition Timeline and New Device Classifications
The EU MDR will be fully effective in all EU member states and European Free Trade Association (EFTA) States from 2021 and provides manufacturers a transition period of 3 years to fully comply with it.
The new European medical device regulations, as observed, have also brought changes to existing device classification system such as:
From identifying exact changes to be made to implementing them in real-time, manufacturers may have to navigate through array of challenges to comply with MDR. Right from decoding the new structure, classifying a device accurately, to collate and submit all the data, a more detailed and cross-functional Regulatory approach will be required for manufacturers to cope with the new medical device regulations. With a stringent gap analysis, Freyr assists clients with the status-quo and there by provides necessary Regulatory action needed for the transition.
- Developing a clear Medical Device Regulation (MDR) implementation strategy
- Understanding the new legislation, conducting gap analysis to current quality management systems (QMS) and processes in place
- Developing a detailed plan with a cross-functional approach to determine aspects of quality system that will need modification in purview with the new EU Medical Device Regulation.
- Forming multiple teams for analyzing product scope, classification, handling QMS etc. within organization with a single point of contact in each team
- Allocation and planning of resources
- Considering your QMS interaction with other regulations and utilizing this opportunity to streamline processes while allowing flexibility to incorporate future changes
- Analyzing the test data in place and check for any additional requirements that IVDR puts in place
- Coordinating expectations and transition plan with your Notified Body
- Gap analysis for existing medical devices from MDD to MDR
- End-to-end support to develop clinical evaluation report (CER) including literature search as per European Medical Device Regulation (EU MDR) guidelines
- Regulatory resource augmentation with both onshore and offshore deployment options
- In-country representation/ legal representative services
- Device registration and submission assistance to global health authorities
- Regulatory intelligence covering importation process of different regulated markets
- QMS compliance and mock audits
- Document management system and tool for MDR companies
- Classification and Reclassification of devices according to risk
- UDI implementation and consulting
- Post-market Surveillance
- Risk management ISO 14971 consulting
- Inhouse and online training
- Person responsible for Regulatory compliance services and assistance