The MDR and IVDR Changes
The new regulatory framework being introduced is currently reshaping the medical device industry landscape rapidly. Complex and stricter rules being introduced has forced companies to revaluate their business models to accommodate the new regulatory changes.
The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) was published 26th May 2017. For the MDR, the rules will come into effect 26th May 2020 and for the IVDR 26th May 2022. The reason why these new regulations are being implemented is to heighten the safety of medical devices within the EU. These regulations are also being created due to the rapid changes in technology in the scientific space.
The Role of Regulation Change
Unlike the Medical Device Directive (MDD), the MDR is more focused on the lifecycle approach to the medical device regulation. The MDD was more of a manual for medical device companies to get their CE marking and to bring their devices to market. However, the MDR approaches the role of the medical device companies and the device’s product lifecycle.
Businesses need to start preparing for the MDR changes now before the regulations come into effect. If businesses cannot provide suitable clinical evidence for new and existing products, they will not be able to sell their devices on the market.
What are the Increased Costs?
This new regulation will come with increased costs from new IT systems and increased labour. Businesses will not currently have the systems that will support the new regulatory changes and this may need to be updated. Labour will need to be increased alongside training them with the skills to manage the new changes. Lastly, there will be costs associated with handling the increased activities such as audit.
At this year’s Outsourcing in Clinical Trials Medical Devices Europe Conference, we have delved into the current industry trends and changes and outsourcing challenges. We have TUV SUD and UL International speaking at this year’s event about the regulatory changes within the industry. Come and learn from them about the changes that are currently taking place and how to implement them effectively within your business. Click here to book yourself a spot!
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