Brian Moan, director of Solutions Delivery Europe and Norm Rabin, director of Solutions Delivery at Maetrics.
Framework
The previous regulatory framework for in vitro medical devices was heavily criticised for not doing enough to improve patient safety, leading to calls that “a robust, transparent and sustainable regulatory framework for in vitro diagnostic medical devices that is ‘fit for purpose’ should be put in place.”[1] This call was heeded and after much deliberation a revised legislation was approved by the European Parliament on 5th April 2017.
So, what changes do IVD manufacturers need to make for compliance? The new legislation is unprecedented in terms of the complexity and number of its requirements. It will have an impact on the way future products are marketed and the way already marketed products are controlled and regulated. Some of the most significant changes impact on the following:
Scope and definitions of devices
Under the new IVDR the number of definitions of an IVD has increased to 74 and it is more prescriptive in defining different types of diagnostic procedure. For example, medical software now falls within the definition of an IVD.
Classification and Conformity Assessment Requirements
A new risk-based classification system dividing IVDs into four classes replaces the general IVD category and prescribes specific actions depending on classification. Class A IVDs, the lowest risk, will not require the involvement and oversight of a Notified Body (NB) whereas Class B devices must undergo a quality systems audit with a NB.
Market Access of Legacy Products
All products to be placed on the EU market after the five year transition period have to be CE marked in their own right. There is no provision for grandfathering certification obtained under the previous legislation.
The Life-cycle Approach
The new IVDR requires clinical evidence and post-market follow-up through means of performance evaluation plans and reports. It explains to manufacturers how to demonstrate scientific validity and both analytic and clinical performance. An electronic database called EUDAMED will be introduced where manufacturers can report serious incidents, safety corrective actions and field safety notices identified by their post-market follow-up.
Mandatory Product Liability
Manufacturers must be in a position to provide sufficient financial coverage for their potential liability. This provision will be based on risk class, type of device, and size of the business.
Supply Chain
Each IVD manufacturer must appoint a suitably qualified Person Responsible for Regulatory Compliance (PRRC) to oversee implementation of the IVDR throughout the entire supply chain. They will work with business partners to address and agree changes to strategies in order to achieve timely regulation compliance.
Labelling
The new IVDR is more prescriptive in its product labelling requirements. For example, it stipulates that labelling information supplied by a manufacturer must be made available and kept up-to-date on their website.
This is just a snapshot of some of the changes IVD manufacturers must address to ensure they are IVDR compliant by the end of the transition period. With countdown to implementation deadline day already well underway we cannot emphasise enough the importance of early action to make sure your business is IVDR ready in time. IVDR conformance will place a considerable administrative burden on organisations. Staffing and budgets should be carefully considered and adjusted to guarantee timely access to the EU market is not compromised.
Be especially mindful of the need to engage the service of NBs at the earliest opportunity as they are already operating at the limits of their capacity and demand for their support will be high. Remember that the classification overhaul will oblige manufacturers to seek agreements with NBs for IVDs that were previously exempt. For many manufacturers, partnering with an outsourced specialist will be the best way to ensure a successful transition and gain competitive edge. Those who plan and implement sooner rather than later will have the best access to limited resources and will be able to cherry-pick their preferred consultants.
Conformance with the new IVDR is a significant business challenge. Manufacturers must be proactive and start planning now to overcome this obstacle and achieve a positive road-map for regulatory success.
For more detailed information on the IVDR, download our whitepaper here.
[1] http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0746&from=EN
