The In Vitro Diagnostic (IVD) industry is about to undergo significant change. In Vitro Diagnostic Regulation (IVDR) has entered into force, marking the start of the transition period for manufacturers selling IVD devices. Now it is necessary for the manufacturers to update their technical documentation and processes to meet the new requirements.
The new Regulation addresses the challenges posed by the previous legislation, including a new rule-based classification system for products, supplanting the current list-based approach. This makes the regulation more practical, by allowing it to remain pertinent to an innovative and growing industry. With this, a far larger number of IVD manufacturers will require a notified body to certify their products. In addition to the change in classification rules, there is an increased harmony between IVD Regulation and equivalent Medical Device Regulation, focusing on clinical evaluation.
There are three areas which deserve special consideration for the manufacturers to be in compliance. They are,
1. Risk-based classification: The new IVDR introduces a risk-based classification scheme and replaces the general IVD classification. Manufacturers have to demonstrate scientific validity, analytical and clinical performance.
2. Technical documentation requirements: Under the new regulation manufacturers will need to fully redesign technical files to meet the new requirements.
3. ISO standards: The new IVDR incorporates several elements of medical device ISO certification. The new regulations brought an increased emphasis on integrated risk management during clinical development and post-market scrutiny. Manufacturers will be required to take steps to bring down the risk of user error. ISO standards also demand that the manufacturers operate on a quality management system.
Agreement with these new IVDR will be a significant business challenge. Manufacturers must be proactive to overcome this pain point to achieve success.