What will the new EU regulations mean for in vitro diagnostics?In 2022 the long-running IVDD will be replaced by another system called IVDR, thus inaugurating a new era for the regulations of InV. Manufacturers aiming for European market access to receive the CE label will face more stringent, more thorough considerations.The IVDR is expected to [...]
The EU IVDR Regulation - An Overview - Part I The PIP breast implant scandal brought to light weaknesses in the overall regulatory process to control IVDs. It may include - The certification system by Notified Bodies (NBs), The need for risk-based classification and more clinical evidence through the device lifecycle. Thus, to better [...]
The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation shall be May 26, 2020. Formed today, introducing the new regulations means that the medical device maker will invest in technology enabling tracking and improving safety management. EU MDRs introduce a new [...]
The EU MDR Delay - What It Means For Your Medical Devices With the global COVID-19 pandemic disrupting industries, stakeholders in the medical devices industry have rapidly diverted efforts from the short-term urgency of ensuring regulatory compliance by 26 May 2020 to provide the immediate delivery of vital medical devices. Given that the EU [...]
EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity assessment process is that clinical evaluation reports are essential to sell or distribute your devices in Europe. However, many manufacturers struggle to comply with European CER requirements as there is a significant [...]
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its conformity assessment procedures. Through the CEAR, the MDCG aims to standardize the documentation of the NBs’ assessment of manufacturers’ clinical [...]
The Post Market Surveillance Series (Part 2) Part 2: Vigilance and Incident Reporting In the second post of our Post Market Surveillance series we’re going to dive into incident reporting and vigilance. This section of MDR deals with how your firm monitors for and then responds to any events reported [...]
The Post Market Surveillance Series (Part 1) Post Market Surveillance in MDR There are only a handful of explicit things that you HAVE to do under MDR for PMS, however there are a lot more things you SHOULD be doing to continuously monitor and update your products’ risk-benefit analysis. Because [...]
MDR Date Of Application Is Approaching Introduction The May 2020 deadline outline in Reg 2017/745 is a cutoff for new filings under MDD, the previous regulation. If your product is already CE Marked under MDD, you do NOT necessarily have to re-certify by the 2020 date but could keep your [...]
Periodic Safety Update Reports: Why You Might Need One Did you know that the Literature Searches you submit for your CE Marking Clinical Evaluation Report might have to be re-run annually? Most that have already submitted an MDR compliant CE Marking Dossier for their products are aware of the need [...]
