EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation [...]
Literature Reviews for EU MDR
Want to know what the most commonly criticized document in an MDR submission is? [...]
12 EU MDR Guidance Documents You Need
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but [...]
Post-Market Clinical Follow-Up (PMCF) Studies for Medical Device Manufacturers
While post-market clinical follow-up (PMCF) played a part in the MDD (Directive 93/42/EEC), the [...]
Marketing Medical Devices in the UK vs the European Union
Until January 2021, medical devices in the UK were regulated under the European regulatory framework. [...]
What Is a Legacy Device, and What Do Manufacturers Need to Know About It?
The MDR is a sweeping reform of medical device regulation in Europe that aims [...]
Post-Market Surveillance – Responsibilities of Medical Device Manufacturers
Post-market surveillance is a significant part of any medical device manufacturer's responsibilities, especially since the [...]
Updates of the MDCG 2019 9 Rev 1, SSCP, and Others
The term summary of safety and clinical performance has recently sent the medical manufacturing world [...]
Essentials for Your EU MDR Checklist
The Medical Device Regulation (MDR) has been a regulatory framework since 2017. The MDR [...]
Market Surveillance – Responsibilities of National Regulatory Authorities
We've explored post-market surveillance (PMS) for medical device manufacturers many times, for example, [...]