Tis 9 aug / År 40 / Nr 3 2022

New MDR and IVDR provide both challenges and opportunities

Most pharmaceutical and medical device developers need guidance to come to terms with new and changing regulations. They also need competent hands-on support in times of high workload. Not least, concerning the new regulations of medical technology products, MDR, and the new IVDR for in-vitro diagnostics.

Jan Hellqvist CEO, Key2Compliance

Pharmaceutical companies, In-Vitro Diagnostic Companies and Medical Device developers are among the most regulated businesses in the world, with ever increasing requirements. For individual innovators or SMEs, it can be difficult to keep track of changes in the legislation and new requirements concerning their activities. On top of that – failing to meet a new requirement can be costly and in the worst-case result in project shut-down. 

Key2Compliance focuses on assisting companies in the Life Science area. Services include Regulatory Affairs, Quality Assurance, Biological Evaluations and Toxicology and Clinical Development services exclusively for Medical Device and Pharmaceutical companies involved in development, manufacturing and beyond. The extensive programs for GMP and Quality Systems Training includes both Pharmaceuticals and Medical Device products throughout the full product life cycle.

The challenges – and opportunities

It is generally estimated in the industry that about half of all existing medtech products will disappear from the market after MDR. The same may apply to in-vitro diagnostics now in connection with the launch of IVDR.

According to the new regulations, both medtech companies and in-vitro diagnostics companies must be able to prove both safety and efficacy with their products. Clinical evidence is required that has not previously been mandatory. Companies must update all their technical files, document all steps in the development process and prove the effectiveness of the product. This will lead to patients having access to much better and safer products.

For companies, new opportunities will open up to develop more targeted treatments in new areas. The products that disappear will leave a void in the market that must be filled.

Supporting into the future

Key2Compliance helps medical technology developers to document the entire journey with clinical studies. To comply with the regulations, companies must perform and report Clinical Investigations and Clinical evaluations. In-vitro diagnostic companies need so called Performance studies, which Key2Compliance can also help with.

The regulations are new in Europe, but similar regulations have existed in the USA and Asia for a long time. It may well be that the United States chooses to tighten the requirements within the FDA shortly. Then the rest of the world needs to keep up with that development as well.

“Our most important asset is our dedicated staff”, says CEO Jan Hellqvist. “Our team consists of specialists from all over the world, with long and broad expertise in all aspects of the development of medical devices and in vitro diagnostics”.

Key2Compliance are focussed on the changing regulatory industry and supporting their clients into the future.