The impact of Covid-19 on the European medical device market
Dr Archana Nagarajan, a freelance scientist specialising in medical devices at Kolabtree, an online freelance platform for scientists, explains the changes made to the European medical device market in light of the pandemic.
Whether it is ventilators needed in emergency and intensive care, Personal Protective Equipment (PPE) or In-Vitro Diagnostic (IVD) kits to detect the virus, the medical device industry finds itself at the centre of the efforts to fight the coronavirus. It has become imperative for medical device companies to be able to handle the sudden surge in demand for equipment and perform further research.
The medical device industry needs to keep up with demand, despite suppliers’ factories shutting down production, reduced factory working hours, a reduced workforce, and often, the shutdown of research and development. It is certainly a challenge to bring innovative new products to the market during these times.
Changes to the EU regulatory landscape
1. Postponement of EU Medical Device Regulation (MDR) application
Due to the coronavirus crisis, the European Commission decided to postpone the change from MDD to MDR, due to be implemented on May 26th 2020, by a year. This allows the medical device industry and Notified Bodies (NBs) to focus on the problem at hand and put all their efforts into combating the coronavirus.
However, there has been no word on the postponement of the In Vitro Diagnostic Regulation (IVDR) 2017/246 yet, which comes into effect on May 26th 2021. This puts some extra pressure on IVD manufacturers as they must be on track for the changes they need to implement to transition to IVDR. Alongside this, they must keep up with the increased demand for critical diagnostic tests and the challenge of kit production and distribution during the pandemic.
2. PPE and relevant medical devices may be placed without CE marking
Some NBs, including in Germany, the UK and France, have relaxed the rules temporarily around CE marking for PPE and urgently needed medical devices. These are in short supply and countries need to purchase them or import them even without CE marking. However, to ensure that quality standards are met, products must be marketable in US, Canada, Australia or Japan, and have instructions for use available in the local language. Thus, medical device companies must now consider and discuss with the relevant NBs to see if their product can benefit from these temporary regulations.
3. European standards and other technical documents are now available for free
The European standards organisations, the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) and several of the national organisations, for example, the German Institute of Standardisation (DIN), have made standards and technical documents relevant to PPE and medical devices available for free until further notice. Thus, these standards can now be downloaded online free of cost.
4. Export of certain medical devices requires authorisation
The European Commission has temporarily made the export of certain medical devices like PPE and other such protective equipment subject to authorisation. This might be difficult for medical device companies contractually obliged to supply devices to countries outside of the EU. This authorisation does not apply for Norway, Lichtenstein and Switzerland.
5. Suspension of inspection by NBs
Most NBs have suspended their on-site inspections and audits temporarily, and encourage companies to follow the required standards and Good Manufacturing Practice (GMP) recommendations.
Conclusion
Due to the current pandemic, the medical device industry has been under tremendous pressure to deliver and innovate, and NBs and the European Commission have been proactive by making decisions to help the industry and the population help fight the virus.