After lengthy deliberation, agreement was finally reached over the new European Union In Vitro Diagnostic Medical Device Regulation (IVDR), which was approved by parliament on April 5, 2017 and published in the Official Journal of the European Union on May 5, 2017. The previous regulatory framework for in vitro medical devices came under significant criticism, thus it is important that the new regulation addresses the flaws and contributes further to improving patient safety.
The introduction of the new IVDR means that medical device companies are going to need to re-evaluate their existing regulatory and compliance strategies in order to position their business to meet the new requirements. In this article we look at changes that manufacturers need to address for compliance, as well as how to achieve a positive road map for regulatory success.
The new IVDR will have a significant impact on manufacturers, which means they need to be armed and ready to implement the changes into their businesses. Some of the expected changes include:
Scope and Definitions
The number of definitions of an IVD has been expanded to 74, and the text is far more specific in defining different types of diagnostic procedures. This means that some manufacturers may come under Notified Body scrutiny for CE Marking that was not previously regulated. Therefore, manufacturers should review the scope and definitions to understand what conformity assessment route they will need to take.
Classification and Conformity Assessments Requirements
A new risk-based classification system that considers the impact on the patient has been introduced. This replaces the general IVD category and uses seven implementing rules, according to Annex VII, to divide IVDs into four classes, with A being the lowest risk and D being the highest. Manufacturers of IVD medical devices should carefully examine the IVDR Classification rules in Annex VII to determine whether new conformity assessment routes are now applicable to their product portfolio.
Market Access of Legacy Products
There is no provision for grandfathering certification (CE Marks) obtained under the previous directives. All products have to be CE marked under the new Regulation 2017/746. A comprehensive plan will need to be instilled to ensure that all products placed on the EU market are CE marked in accordance with the full requirements of the new IVDR.
The IVDR is significantly more prescriptive about the required content of the technical documentation. In addition to this, there are more detailed requirements for quality management systems (QMS); EN ISO 13485:2016 which was rewritten and issued in 2016 with the new MDR and IVDR in mind.
Clinical Evidence, Performance Evaluation and Performance Studies
The IVDR will require clinical evidence and post-market follow-up, therefore providing a lifecycle approach. This means that manufacturers may need to obtain additional clinical data from clinical studies.
Vigilance and Post Market Surveillance (PMS)
Under the new Regulation 2017/746, IVD medical device manufacturers will be required to collect post-market clinical data as part of their on-going assessment of potential safety risks. An electronic database called EUDAMED will be introduced where manufacturers can report serious incidents, safety corrective actions, field safety notices and periodic summary reports. Manufacturers should closely follow the evolution of the EUDAMED system, which aims to aid transparency—a guiding principle of the IVDR.
Mandatory Product Liability
Manufacturers will have to provide sufficient financial coverage for their potential liability; in order to do so, legal counsel should be sought.
Each manufacturer will have to appoint a Person Responsible for Regulatory Compliance (PRRC). With this in mind, manufacturers should analyze their whole supply chain to ensure all provisions are appropriately met.
More than ever before, the labelling of products will be more prescriptive. Manufacturers should carefully review the adequacy of their product labelling and precautionary statements and consider how this will be reflected on their web-sites.
Notified Body Capacity
There has been a significant amount of publicized safety issues that have contributed to the evolution of the new IVDR. This has resulted in NBs coming under pressure from their Competent Authorities (CAs) to increase scrutiny of their client IVD medical device manufacturers. Not only this, but NBs will themselves need to seek designation under the new IVDR. However, this increased pressure on NBs is only going to exacerbate an already existing issue.
The number of NBs is dwindling despite new regulatory requirements increasing potential workloads. Evidently NBs are already experiencing capacity issues, and with only 56 NBs in the EU in total, it is apparent there will be over-demand from the industry as manufacturers compete for their services (particularly through the testing transition period for the new IVDR).
To increase the pressure further, the new IVDR stipulates that NBs have to carry out unannounced inspections every five years. Manufacturers need to be aware of the capacity issues when planning for IVDR implementation, understanding that NBs themselves may not be able to provide the hands-on support going forward as they deal with their own need to meet IVDR criteria. Increasingly we are seeing medical device companies look to outsourced expertise who can provide the consistent support needed and plug knowledge gaps within their own organization.
Programmatic Approach to IVDR Compliance
It is apparent that the IVDR is going to pose a significant business issue to all manufacturers, and it will not cease at the end of the transition period. Regulatory control over conformance with the requirements of the IVDR is ever increasing. It is important for manufacturers to factor in the financial planning that is required to implement the new IVDR. In the face of significantly enhanced regulatory scrutiny, compliance budgets need to be adjusted to ensure timely access to the EU market. When looking at budgets, it is important for manufacturers to be mindful of the increasing shortage of skilled professionals; resources are limited and early implementers will reap the benefits of available highly skilled consultants. Partnering with an outsourced expert provider will give medical device companies the edge they need to be ahead of their competition and continue to ensure that they meet the requirements for market access.
Increased Access to the Market
It is imperative that IVD manufacturers and other economic operators be proactive and adopt a pragmatic approach to conformance, and that they do this quickly. To early adopters of the IVDR, capacity issues present a competitive advantage just as much as they pose a temporary block to others in the EU market.
The impending capacity gap is only going to tighten and will cause a readiness problem for IVD manufacturers who do not invest early in their compliance preparations. Conversely, IVDR compliance pioneers will be perfectly situated to meet market demands that late movers will be denied access to until they comply with the new regulation requirements. Early IVDR adopters should expect to see a fiscal benefit from taking advantage of this market opportunity, which could only add to increasing overall revenues, as late-adopters may in fact never win back their original stake in the market.
Conforming to the new IVDR is a challenge that must be promptly overcome in order for IVD manufacturers to benefit from continued access to the EU market. Developing a compliance strategy that encompasses all the new and adapted areas developed within the IVDR is critical to patient safety and business success. There are going to be significant capacity bottlenecks, as there are clear indications from NBs that certification capacity will not be sufficient to service all market requirements. Equally, the availability of compliance consultants will diminish as early adopters swoop in. Seeking expert advice and outsourcing the compliance process to ensure successful adoption could certainly be the way forward for in vitro device manufacturers. Early adopter advantage may give them the edge over their competition while paving the way for regulatory success.