The MDR Countdown
The new EU Medical Device Regulation (MDR) will create a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for manufacturers.
Manufacturers need to start now and prepare for this substantial and unprecedented change in the European regulatory environment for medical devices – or risk having their products removed from the market.
When is the deadline for the transitional period?
The transitional period will end on 26 May 2020, the “Date of Application” (DoA) of the Regulation. From that date the MDR will apply fully. To avoid market disruption and allow a smooth transition from the Directives to the Regulation, several transitional provisions are in place. Some devices with certificates issued under the Directives (AIMDD/MDD certificates) may continue to be placed on the market until May 27, 2024 and made available until May 27, 2025. During the transition phase, products certified under the Directives and products certified under the Regulation will coexist on the market. Both will have equal status under the law, and no discrimination in public tenders may take place.
An important reason to act NOW
Facing the complexity of the new regulations for medical devices and in vitro devices, many notified bodies have already announced that they will not apply for accreditation under the new MDR 745/2017.
ECM has already submitted its application for MDR and is scheduled for the joint assessment of the competent authorities by the end of the Summer. In the meanwhile, ECM are still accepting new applications for ISO 13485 and CE certification according to the Medical Devices Directive (MDD) 93/42/EC. The number of available slots is limited, and the window is rapidly closing.
Why is it important to meet ISO 13485:2016 compliance?
Regulation: Meeting product regulatory requirements is a key element of ISO 13485:2016. One key contribution is to harmonize quality management system regulations across various agencies (such as US FDA, CEN, Health Canada). The regulation is aimed at developing safe products which have effective performance.
Documentation; The requirements for document control, documented procedures, manufacturing records, failure records, and customer feedback related to product specifications are far greater in ISO 13485:2016 than in ISO 9001:2015. These requirements include the medical device file, the quality manual, document control that includes handling obsolete documents, roles and responsibilities within the organization, product maintenance, contamination, traceability, monitoring, feedback on performance, and notification to regulatory authorities reporting adverse events.
Continuous Improvement: Improvement requirements in ISO 13485:2016 are designed to maintain the continued suitability and effectiveness of the Quality Management System (QMS)
The deadline is approaching, now is the time to transition. A Notified Body is the best source of expertise for complying with these standards and assuring products and processes meet the standards’ requirements.