COVID-19: How IMed is Supporting the Industry

Here at IMed, our Quality & Regulatory Consultants have been busy adapting to the challenges which face us all, during this difficult time. Adaptation is a vital tool for any business in such an unprecedented commercial landscape. But it’s actually been great to see how members of our all-important medical device industry have been at deploying new strategies, to overcome the obstacles presented by the COVID-19 pandemic.

As a consultancy, it has been an honour to be called upon supporting companies who need our help and advice. More emphasis has been put on getting COVID combatting devices compliant and safely to market, against the backdrop of changing regulations and varying ongoing movement restrictions.

So, with this in mind, we’d like to share some of our thoughts and experience of how IMed has been supporting medical device clients over the last 12 months

Compliance & Regulatory Framework

This time last year, the industry was focussing on three key areas of change;

• Transition to the MDR 2017/745
• Transition to the IVDR 2017/746
• Brexit

When COVID-19 (later Sars-CoV-2) was officially declared a pandemic, global regulators had to very quickly determine their position from a compliance perspective. On both sides of the Atlantic, two strategies emerged in parallel. Whilst both didn’t quite hit the mark at first, they did get there relatively soon after.

In the US, the FDA deployed the tried and tested Emergency Use Authorisation (EUA). Whilst in the EU (including the UK at that stage), The Commission and National Competent Authorities issued a range of support mechanisms to medical device manufacturers, as well as having a greater say on whether a device could be marketed or not. The challenge for both channels was to find the right balance between expediting swift approval to market, whilst still ensuring the full safety and efficacy of device performance.

On the whole, considering the task before them, global regulators did a pretty good job under the mounting pressure of the huge surge in the number of new and critical devices being developed. Some manufacturers were also completely new to the medical device sector, so had to learn and act quickly. And in some cases, we were there to help.

Projects that IMed Supported

Our IVD consultants were asked to help out with a variety of projects. Here are a few examples from the range of activities that we undertook and are continuing to perform:

Technical File Reviews

IMed has been diligently reviewing the technical documentation for a wide range of In Vitro Diagnostic Devices, to ensure compliance to both US and EU requirements, including:

• Real-Time PCR (RT-PCR) for the detection of SARS-CoV-2 RNA.
• Lateral-flow immunoassays for the detection of IgG,IgA and IgM viral Antibodies.
• SARS-CoV-2 Antibody ELISA Test Kits.
• Other Immunological Assays.

Regulatory Strategy

IMed has supported a wide range of clients by helping them to introduce and develop the best possible regulatory strategy in order to get their COVID-19 devices to market as efficiently as possible, whilst remaining compliant to global medical device regulations.  These activities included;

• Strategy for manufacturers of PPE.
• Implementation of a Quality Management System (QMS) e.g. to ISO 13485:2016, Part 21 CFR 820, MDSAP.
• Route to market for manufacturers of IVD test kits and instrumentation.
• Strategy for manufacturers of Sample Collection Kits.
• Labelling requirements.

In summary….

It has been a difficult time all-round, but we must applaud the numerous Herculean team efforts to fight COVID-19; pulling together to provide targeted solutions, which are both rapid and highly accurate.  At IMed, we are pleased to have been involved in the global fight against the virus. We will continue to do our part.

For anyone manufacturing the medical devices discussed here, IMed understands navigating the current and future regulatory requirements can be challenging. In particular, devices that will be reclassified as Class D (highest risk) under IVDR 2017/746, IMed can get you there. Just talk to us as soon as possible.

After the last 12 months of adapting and developing our knowledge of this type of medical device, to keep pace with the demand, IMed’s team are now even better prepared to help anyone, who is currently developing a new device or is struggling with any aspect of their current project. So please don’t hesitate to get in touch with us for our support or to have a chat about anything IVD or medical device related. After all, it’s what we do.