The EU Commission has recently announced that the transition period for completing and implementing EUDAMED has been extended again. The previous target for full functionality was the second quarter of 2024. The new target date for this is now the second quarter of 2027.
Medical Device Consultancy provides tailored expertise to your business, helping to navigate the medical device industry.
With advancements in technology, the need for stringent regulatory and quality assurance services has never been more crucial. In this dynamic environment, medical device consultancy plays a pivotal role, guiding innovators through the complex web of regulations, ensuring compliance, and facilitating the delivery of safe and effective devices to patients worldwide.
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The medical device industry has witnessed remarkable growth in recent years, and its expansion shows no signs of slowing down.
Navigating the Future: The Growing Medical Device Industry and the Role of Regulation Read More »
Person Responsible for Regulatory Compliance (PRRC), is a requirement for medical device and IVD manufacturers and Authorised Representative. Article 15 of regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR), define the legal requirements for a PRRC.
They state that each manufacturer and authorised representative (if applicable) must have at their disposal a PRRC, who has the necessary requisite qualifications and experience for regulatory compliance.
Person Responsible for Regulatory Compliance (PRRC) Read More »
Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP
Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen,
Deutschland / Germany
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