Near-patient Testing (NPT) has the fastest-growing market in the IVD segment. Europe is the second-largest market after the United States for NPT. Many companies are trying to launch their NPT products in the European Union (EU), and now with the implementation of In Vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746, the companies are transitioning towards it.
The importance of medical writing has been highlighted over the years in healthcare and, notably, for medical devices. We can say that the approval from the Regulatory agencies is predominantly dependent upon the medical writing of the medical devices, i.e., the scientific documents devised for the devices. Further, the continuous innovation in the medical device industry has simultaneously strengthened and changed the scope of medical writing.
The establishment of European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 posed additional requirements. The significant aspect highlighted was implementing the Post-Market Surveillance system (PMS). Enabling PMS will ensure the devices' safety even after being launched in the market.
The impact of Brexit has been a major topic for debates amongst the industry experts for the past two years. It has left companies on both the sides, the United Kingdom (UK) and Europe, hanging on a loose thread. As the date of Brexit is drawing closer, industries are aggressively looking for contingency plans for sustaining their business, if the UK leaves with a ‘no-deal’. Coming to the scenario of Life Sciences regulations, if the UK leaves the European Union (EU) with a no-deal, the former will no longer be a member of the EU medicines and medical device Regulatory networks.
Life Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry. With a goal to spread digitalization across each and every aspect of market authorization of medicinal products, national drug regulatory authorities across the Europe along with the European Medicines Agency (EMA) have recently updated a document titled “eSubmission Roadmap”.
What is eSubmission Roadmap?
From 13 June, 2016 onwards
In a recent update, it has come to light that the companies in the UK will no longer be submitting the Periodic Safety Update Reports (PSURs) to the national regulators including the Medicinal and Healthcare products Regulatory Agency (MHRA). Alternatively, the submissions will be directed towards the central repository at the European Medical Agency (EMA), which is going to be mandatory from 13 June 2016.
What is a PSUR?