Are You Over Committing to Your EU MDR Post Market Surveillance Plan?

By |2021-07-10T17:47:43+00:00March 12th, 2021|

  Overview The EU MDR and IVDR will usher in increased post-market surveillance (PMS) requirements for all MedTech companies. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is unnecessary. Higher-risk devices and IVDs will require a Periodic Safety Update Report (PSUR). While for lower-class devices, a [...]

Classifying Software as Medical Device in EU MDR

By |2021-07-10T17:22:59+00:00March 9th, 2021|

Introduction to Software as a Medical Device in MDR The MDCG’s Guidance document defines the criteria for software qualification falling within the scope of the EU MDR and IVDR. This doc even seeks to elucidate which software will be considered a medical device (qualification) and its subsequent risk classification (classification). Although it is not [...]

How to Hire a Literature Search (or CER) Writer and What to Look For?

By |2021-07-11T17:00:08+00:00January 27th, 2021|

INTRODUCTION A literature search is a deliberate and efficient search from already distributed information to distinguish between a good quality reference on a particular topic. There are different reasons for conducting a literature search, including drawing information for making evidence-based reports, academic assessment, and a step in the research methods. A thorough literature search [...]

UK details a Post-Brexit Medical Device Regime Starting January

By |2021-07-11T17:26:46+00:00December 14th, 2020|

With ongoing negotiations over a trade deal between the UK and the EU and less than 30 days until the end of the Brexit transition period, the UK Government continues to flesh out guidance on regulating medical devices. Given the current circumstances, the Brexit transition period will end without a trade deal in place [...]

Post-Brexit Medical Device Regulatory Compliance – UK MHRA Guidance

By |2021-07-18T18:22:26+00:00November 26th, 2020|

What the Medicines and Healthcare products Regulatory Agency does MHRA is an executive agency in the Department of Health and Social Care. The Medicine and Healthcare products Regulatory Agency regulates medicines and devices for transfusion in the UK. MHRA regulates medicines, medical devices, and blood components. Following the UK Medicines and Healthcare products Regulatory [...]

Your NB’s Clinical Evaluation Assessment Report

By |2021-10-22T05:44:22+00:00October 22nd, 2020|

An Overview of the Clinical Evaluation Report Also abbreviated as CER, a Clinical Evaluation Report is compulsory for all manufacturers who want to put their medical instruments in the European Union’s market. It is important to obtain your European CE technical file to get your CER. The Technical File is an essential step to [...]

An Understanding of the Clinical Evaluation Process in China – Comparison with EU MDR

By |2021-07-22T16:49:28+00:00September 17th, 2020|

Medical device regulations in China are often similar to the European Union (EU)’s MDR. With a vital prerequisite of Clinical Evaluation Reports (CERs), as required by China’s National Medical Products Administration NMPA (formerly CFDA). Although both the forgoing regulatory frameworks permit equivalent devices as a basis for clinical data for a new device, the [...]

Guidance on the classification of Medical Device Software (MDSW) for EU MDR

By |2021-08-21T19:31:47+00:00July 15th, 2020|

Medical Device Software (MDSW) The MDSW is defined as a Medical Device regardless of its location of use. Software that is driving or influencing the use of a medical device can qualify as a device. Software intentionally to process, analyze, create or modify medical information will be considered medical device software if it has [...]

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 [...]

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