Post Market Clinical Follow-Up (PMCF) – Understanding MDCG’s Latest Guidance

By |2021-07-22T17:54:37+00:00June 30th, 2020|

Guide - MDCG endorsed documents and other guidance documents. The majority of documents on this site need approval by the Medical Device Coordination Group (MDCG) as per Article 105 of the MDDR and Article 99 of IRD. The document should draft in coordination with interested parties. Each representing various group groups and being denominated [...]

IVDR Part II – Your Technical Documentation and Performance Evaluation

By |2021-07-17T21:14:08+00:00June 12th, 2020|

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 [...]

EU IVDR – Part I

By |2021-07-18T16:42:51+00:00June 2nd, 2020|

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 [...]

Your MDR Readiness Checklist

By |2021-07-23T19:58:06+00:00May 22nd, 2020|

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 Delay of EU MDR

By |2021-07-24T23:43:54+00:00May 11th, 2020|

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 Requirements – Understanding the CER

By |2021-08-09T20:06:50+00:00May 5th, 2020|

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 [...]

How Your Notified Body Is Grading Your EU MDR CER

By |2021-03-03T20:05:54+00:00January 8th, 2020|

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 [...]

Post Market Surveillance Series – Part 2, Vigilance Reporting

By |2021-07-29T20:14:32+00:00August 22nd, 2019|

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 [...]

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