Regulation as a brake on innovation? How the MDR delays the market entry of medical devices and what companies can do about it
Regulation and special requirements for manufacturing and quality assurance are extremely important, especially in medical technology – after all, human lives depend on it. However, there are repeated discussions that criticize the fact that MDR and IVDR tend to hinder innovation and represent an enormous barrier to market entry. In this blog post, we address these critical voices and explain how companies can deal with MDR and IVDR.
What are MDR and IVDR?
The MDR (Medical Device Regulation) and the IVDR (In Vitro Diagnostic Regulation) are European regulations that govern the approval and monitoring of medical devices and in vitro diagnostics (IVD). They were introduced to ensure a higher level of protection for patients and users, increase transparency and improve product safety in the EU. The MDR came into force on May 26, 2021, and the IVDR on May 26, 2022. Both regulations replace previous EU directives.
What are the criticisms of the MDR and IVDR?
Special challenges for SMEs
For SMEs and start-ups, the new MDR and IVDR regulations are a particular challenge. The higher costs, lack of internal resources, delays in market launch and intense competition with larger companies are putting these companies under severe pressure and many smaller organizations are faced with the decision of whether to continue investing in new products or withdraw from certain market segments. The additional bureaucratic and financial burdens could lead to a weakening of the innovative strength of these companies, which could affect the dynamics of the medical technology and diagnostics industry in the long term.
What could be the solutions?
- State and EU-wide financial support
- Creation of special advisory and support networks
- Easier access to notified bodies
- Simplification of regulatory requirements for SMEs
- Promoting the digitalization and automation of processes
- Promotion of cooperation and partnerships
- Training and further education
- Use software solutions such as BAYOOSOFT Themis
Conclusion
The strict requirements of the MDR and IVDR lead to delays in market access, especially for innovative and complex products that require extensive clinical data. Smaller manufacturers, who are often innovation leaders, are burdened by higher costs and longer testing procedures. There is a risk that innovation will be slowed down as companies have to focus more on regulatory compliance and recertification of existing products. This could have a negative impact on progress in medical technology and diagnostics and delay access to new, potentially life-saving technologies. Solving the challenges faced by SMEs in particular as a result of the MDR and IVDR requires a holistic and flexible approach. Financial support, regulatory relief, access to resources and notified bodies and increased cooperation can help to reduce the burden on SMEs. Through these measures, SMEs can maintain their innovative strength and retain their role as important players in the field of medical technology and diagnostics. However, it is also important for companies to become active themselves and help to speed up processes. Software solutions help with this by digitizing documentation processes and thus significantly reducing costs.
MDR and IVDR-compliant technical documentation with BAYOOSOFT Themis
BAYOOSOFT Themis provides you with a validated solution for the technical documentation of medical devices and for the documentation processes of quality and information security management systems. This allows you to digitize and link your processes, reduce effort and minimize redundant data. This allows you to optimize your technical documentation in accordance with MDR and IVDR while ensuring efficient and compliant management of your documents.
Our specialized modules cover all relevant requirements for medical devices and management systems – from risk assessment and technical documentation to compliance with international standards and regulations such as MDR, IVDR and quality and information security standards.
