The European Medical Device Regulation ensures high standards of quality and safety for medical devices being produced in or supplied into Europe.
The regulation places a renewed focus on standardised data and establishes an EU database (Eudamed) to better identify medical device products and improve transparency.
Distributors of medical devices in Europe must comply with all relevant aspects of the legislation, which includes being able to provide full product information for any medical devices or parts handled to ensure traceability and verification of origin and authenticity.
Why the Medical Device Regulation is being implemented
The medical device market has undergone many changes and advancements since the previous Medical Device Directive (MDD) came into law in 1992.
To reflect this, the Medical Device Regulation (MDR) was introduced and represents a significant development and strengthening of the regulatory system for medical devices in Europe.
MDR aims to provide a robust, transparent and sustainable regulatory framework to improve safety for those relying on medical devices.
What happens if distributors aren’t compliant?
Notifying bodies will complete MDR audits to ensure that distributors of medical devices are in conformity with the regulation once it comes into force.
The consequences for failing an audit can range depending on the product itself and the severity of noncompliance, including fines or potentially the removal of the product from the market.
What steps can distributors take to comply with the Medical Device Regulation?
The new obligations facing distributors under MDR should act as a catalyst to create a systemic process for storing and tracking all information that is required to ensure the traceability and authenticity of devices handled.
Given the complex string of information attached to every medical device or part – including a unique identifying number, product code, lot number, serial number and expiry date – old manual systems of data collection will no longer suffice under MDR.
Here are three steps for your business to follow to comply with MDR:
1) Implement electronic warehouse and inventory management systems
Electronic quality management systems automate much of the data collection required when handling medical devices, greatly aiding compliance with MDR.
Having a business management solution in place with fully integrated warehouse management functionality, helps medical device distributors with tracking and batch traceability of all parts.
Systems can automatically capture records of where materials have come from and where they have gone to, while enabling distributors themselves to easily identify the origin and authenticity of a part.
2) Equip staff with mobile inventory management devices
Introducing handheld scanners on mobile devices will also improve inventory management by helping staff to efficiently receive, pick and prepare sales and purchase orders, all the while ensuring accuracy.
3) Streamline wider business operations
Distributors can leverage the power of sophisticated data management solutions to do more than just track and trace medical devices and parts.
Keeping functions of a business such as warehouse management siloed away from other areas leads to inefficiencies and difficulties in forecasting and planning.
This is the perfect opportunity for distributors to implement an integrated platform that compiles data from across the organisation to create a complete view of the business.
How can distributors digitally transform their business?
Business management solutions can certainly help distributors to comply with new obligations under MDR by automating much of the track and trace processes.
Automating processes also help distributors to overcome common challenges and remove inefficiencies.
Replacing time-consuming manual data input when transferring stock and enabling automatic updates to the nominal ledger with cost of sales, cost of purchases and stock valuation all facilitate faster and better informed planning and decision-making within a business.
Preparing your business for the Medical Device Regulation coming into force should be one of your top priorities. Making sure you comply with the new legislation is vital.
Ultimately, an electronic quality management system is an essential tool that can help your business to comply.
Modern software and technology solutions can also be utilised to transform the entire organisation – helping you to run a smarter, faster, more connected and efficient business.
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