The new EU Medical Device Regulation will come into effect on the 26th May this year, completing its transition period to replace existing regulation boards.
Are you ready for the change? Find out more below.
What is changing?
The EU Medical Device Regulation will apply to any manufacturer selling medical devices within Europe. This will bring a number of improvements and changes to the industry, meaning that public safety will be more greatly protected.
The cost of complying to the new MDR is estimated to be between 4-7% of annual revenues, industry wide. However, failure to comply will result in loss of business within the EU and other global markets.
What does this mean for businesses affected?
All medical device companies must demonstrate and maintain compliance in accordance with the new MDR by 2024.
However, rather than viewing this as a compliance, tick-box exercise, the regulation actually provides a number of opportunities to companies if done swiftly. These include the chance to:
- Get ahead of the competition. Some businesses may not be able to invest in the changes at the current time, providing plenty of opportunities for growth.
- Manage and enhance patient safety, and provide greater assurance of product performance. This will allow businesses to rectify any previous incidents, ensuring that products are safe, efficient and high-quality.
- Drive harmonization and efficiency. Multiple business units may be benefited by streamlining processes to work in unison with the regulations.
- Plan strategically. Businesses will be able to revise plans to address potential revenue gaps due to product withdrawals, re-certification and supply continuity.
Acting early and getting ahead of the MDR rush, therefore, provides a range of benefits.
How can CK QLS help?
The changes coming into effect will mean that more contractors are needed to assist with the transition.
CK QLS are able to provide staffing solutions to your all of your temporary and permanent recruitment needs.