How to Prioritize Medical and IVD Equipment Under the New MDR / Ivdr in Europe

Experts discussed how to prioritize medical and IVD equipment under the new MDR / ivdr in Europe.

The latest medical device regulation (MDR) and in vitro diagnostic medical device regulation (ivdr) adopted by the European Union in May 2017 strengthen regulatory requirements, aiming to create a more transparent and unified process to certify new medical devices and in vitro diagnostic medical devices (IVD devices) and re certify existing devices. Manufacturers have three and five years respectively to meet the requirements of MDR and ivdr. Some of the challenges facing manufacturers are:

Is it cost-effective to revalidate the entire product portfolio when the investment in some projects may exceed the benefits?

How to expand the data collection resources and post IPO monitoring / performance evaluation required by the new legislation?

What is the new role of the third party appointing authority? How will our relationship with them change?

Can our class III implantable devices or class IIB active device products use or not use pharmaceutical products that may require further review by the conformity assessment procedure?

What is the best time frame to start implementation? How long does it take?

This article will outline a three-step process to identify products with the highest commercial value and help you prioritize medical and IVD devices to meet the requirements of the latest MDR and ivdr.

01

Internal evaluation

First, manufacturers need to take an inventory of their entire product line and portfolio to determine the category of each product. At the same time, they need to pay attention to which devices are reclassified as medical devices (such as disinfection and sterilization products) or classified as class III medical devices (such as heart repair mesh fabric and joint replacement devices). The new content of ivdr is gene test and auxiliary diagnosis, which can predict treatment response or individual patient response.

From standard supervision opinions to patient data and the needs of clinical trials, the investment of products varies greatly. Based on the difference between additional compliance costs and future revenue potential, consider what areas are worth promoting. Consider that buyers may prefer devices certified by the new rules. In some cases, it may be more cost-effective to update certain products according to existing directives, so they can be used temporarily until the certificate expires in 2024. Consider how you will meet the increased data collection and reporting requirements under MDR and ivdr, such as post market monitoring. Then develop a gap assessment and closure plan and what you will do in the future to meet the requirements of the new regulations.

02

External verification

Secondly, it is important to interview customers to get the market's evaluation of your products. This process can help you validate internal assumptions, especially strategic drivers, and determine the contribution of your portfolio to the company's and brand value proposition. In addition, you can assess the impact of removing different products from the portfolio from a business, regulatory, and compliance perspective. Then create a product priority list and sort each device and diagnostic tool according to commercial importance.

03

Prioritization and Implementation

Finally, by integrating the findings of internal and external workflows, you can prioritize your portfolio. At this stage, you can decide which products will be de prioritized and may be withdrawn / eliminated. In step 3, you need to perform financial calculation / simulation, including the calculation / simulation of net present value (NPV), to understand the financial impact of portfolio adjustment. You need to assess resource needs, including return on investment (ROI) reviewed by regulators.

In terms of personnel, it is useful to develop a roadmap for the roles and responsibilities of activities and implementation planning. According to the new rules, you need to appoint a person with the necessary qualifications and training as the "person in charge", whose responsibility is to supervise the collection of clinical evidence, quality data and post market monitoring information. He is also responsible for ensuring that safety and performance issues are adequately addressed.

Please note that NBS will now play the role of regulatory executor rather than industry partner. According to the new regulations, NBS is responsible for providing sufficient and appropriate qualified personnel and has the right to review specific categories of devices. We expect that NBS may lack resources to certify certain devices, which may lead to delays and increased costs. Assess how the availability of NBS services will affect your development and certification schedule, and Book services as needed.

In addition, develop a plan according to the requirements of the latest regulatory documents and compare it with your work in progress to identify all gaps and determine how to eliminate them. The technical documents of MDR and ivdr include various requirements, such as what should be included in the pre certification and post marketing monitoring reports, the frequency of submitting reports, the way of preparing reports, and who is responsible for these reports.

In addition, you need to assess whether resources comply with new product labeling laws. At present, there are significant changes in the label, simpler language is used, the label wording is consistent, and patients receiving implantable devices must show the implant card. In addition, labels and other documents must include a device unique identifier (UDI) to help track medical devices for performance monitoring, safety alerts or product recalls throughout the product life cycle.

04

smooth transition

For a smooth transition to the new MDR and ivdr, you need early intervention, foresight and an action plan. Icon and Simon kucher & partners have cooperated to conduct comprehensive regulatory and commercial evaluation of existing and developing medical devices and in vitro diagnostic medical devices. We work together to help customers prepare business plans, determine which products should be certified or re certified and which products should be recovered according to revenue and profit. We also help you create the vast amount of evidence of reality (RWE) needed to comply with the new regulations. In addition, in the long run, we save money by helping you conduct continuous product monitoring and performance evaluation through electronic health records for data collection and automated site management. In addition, icon's medical device supervision team can help you correct the defects of technical documents by updating existing documents or preparing new reports.

How to Prioritize Medical and IVD Equipment Under the New MDR / Ivdr in Europe 1

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