Maetrics reveals the practical implications for medical device manufacturers and how to address them as the new MDR comes into force
June 2017 – Agreement has at last been reached on the new European Medical Device Regulation (MDR), which officially came into effect in May 2017. The new regulation has consolidated two existing legal provisions and replaced both the current Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC). The new MDR will inevitably bring about important changes within the industry so it is imperative that manufacturers understand the full impact of the MDR on their business and do not delay formulating a strategy to ensure compliance.
In order to help manufacturers understand the imminent changes and their impact, Maetrics, a leading international consulting firm focusing on providing life science companies with deep quality, compliance and regulatory solutions, has published a free whitepaper that is available to download here: New Medical Device Regulation Requirements
Peter Rose, Managing Director, Europe at Maetrics, explains “the new regulation is going to bring about an unprecedented change to the European regulatory environment for medical devices. This must-read guide comprehensively lists the changes to the regulatory framework and highlights a preferable course of action for manufacturers to take in order to sufficiently prepare for MDR.”
The guide particularly focuses on:
• Significant changes in the MDR and their implication for manufacturers, including: reclassification, market access of legacy products, reprocessing of single use devices, technical documentation, clinical evaluation, vigilance and post market surveillance, mandatory product liability insurance, transparency, supply chain, labeling, and UDI;
• Practicalities of implementation, looking closely at: Brexit, Notified Body capacity and numbers, Delegating Acts and the ISO 13485 Quality System;
• Suggested next steps, which include suggested steps to achieving compliance.
Jens Weirsoe, Director Solutions Delivery at Maetrics in DACH, comments: “The New Medical Device Regulation is a complex document and the changes it embodies are significant. The new regulation comes with a three year transition period following its publication and is expected to come into full effect in 2020, after this date it will no longer be possible to put a new medical device on the market with a CE mark issued against the former Directive 93/42/EEC so it is vital that businesses sit up and take notice now.”
Mike Wolf, Director Solutions Delivery at Maetrics in North America, adds: “this new whitepaper is extremely easy to read and should be used by manufacturers as a practical tool in order to not shirk on compliance. The whitepaper provides an easy to follow checklist for manufacturers to ensure a pragmatic approach is taken to achieve MDR compliance. Since this new European Medical Device Regulation came into effect, one thing is clear – manufacturers must begin preparing for the changes as a matter of urgency.”