New EU MDR Presents Opportunities for Manufacturers


MDR and IVDR are Coming - Are you Prepared?

After the May 2017 release, manufacturers have three and five years to comply with MDR and IVDR, respectively. Are you prepared to meet the new regulations?

Forward-looking manufacturers and sponsors may find a silver lining in the European Union’s new medical device regulation (MDR). Challenging as its product testing and reporting requirements may be, the MDR also could present an opportunity to get a jump on the competition. Early planning is the key.

On 26 May 2020, any medical device sold in the EU – and likely the UK and countries around the world that embrace EU standards – must be certified under the new MDR rules. Major changes include1:

  • Increased clinical performance reporting for the certification and recertification of many products
  • Post-market surveillance and performance assessment for most devices
  • New labelling requirements and Unique Device Identifier numbers for all devices
  • Reclassification of some devices, and certification for the first time of others, including sterilisation equipment and primarily aesthetic devices

Details of the new requirements are available in ICON’s white paper, Getting Ready for Europe’s New Rules: A Guide for Successfully Developing and Commercialising Medical Devices and In-Vitro Diagnostics under MDR and IVDR. 

In addition, the role of Notified Bodies (NB) will change from industry partners to regulatory enforcers. NBs also will be restricted by the European Commission to certifying only the specific classes and types of medical devices for which each NB can demonstrate expertise. This will reduce the number of NBs available to certify many devices for some time. And, in combination with the larger volume of clinical data that NBs will have to review for each device, we expect long delays in certification reviews as the 2020 deadline approaches.

The MDR will affect virtually every aspect of medical device development and marketing in Europe. Here, we address a few questions about how sponsors can respond – and perhaps even benefit – from the complex challenges the MDR presents.

When should I start preparing for the new MDR?

Right now. While three years may seem like a long time, complying with the MDR will require significant lead time, especially when preparing clinical studies to certify new devices – and to recertify many existing ones. Moreover, you’ll need to build in extra time for expanded NB reviews, and any NB review backlog that may develop.

Getting your product in the NB review queue early will help avoid disrupting your access to the EU market due to certification delays – which could give you a market edge over slower competitors.

Clinical testing of new and existing products sounds expensive. Will it be worth the investment?

The way to find out is to conduct a “gap analysis” of your existing pipeline and product portfolio. For each product, determine what category it will be certified in under the MDR, and what, if any, additional clinical testing, production process, technical file documentation, labelling or other changes will be required to conform. Then, estimate the cost of these changes, assess how they will affect profitability, and reconfigure your portfolio accordingly. Your analysis may well indicate that it’s time to drop marginal products with a lot of competition and focus on preparing packages for new, more profitable, devices where there are fewer marketplace competitors.

Keep in mind that the MDR requires uniform performance data reporting to a central database, which will make it much easier for health system buyers to compare product performance head-to-head. As a result, any product that can show a clear performance edge could gain a decisive market advantage. Tailoring products to clearly defined needs of specific patient populations and indications, and developing clinical test strategies that clearly demonstrate effectiveness for such populations, will help you gain and press your market advantage under the new MDR.

How can I keep clinical performance testing certification requirements from delaying or disrupting market entry?

Several strategies can help keep medical device development on schedule, while addressing the MDR’s clinical testing and performance reporting requirements. These include:

  • Integrating performance testing with early-stage development. This could involve parallel open-label testing of devices in broader populations for clinical and economic outcomes such as the impact of a device on the use of other medical services, alongside any narrower clinical study needed for CE marking.
  • Incorporating adaptive design elements into clinical trials. This could accelerate development by combining trial stages, and could even enable a continuous learning development process in which data from earlier device versions support applications for new variations.
  • Automated data collection using electronic health records, which could reduce data collection costs while broadening the scope of data collection, especially for post-market surveillance.
  • Risk-based monitoring of trials and post-market surveillance, which could help spot protocol deviations or device performance issues early on, enabling quick corrections to bring trials and the entire development process back on track.

Early transition to the MDR could give your products a competitive advantage in the market by providing buyers with credible performance information. In addition, it could give early movers an edge in squeezing out other device developers competing for the same limited NB resources required to comply. ICON can help you to quickly assess your portfolio for product viability under the new regulations, and to move forward in creating the substantial body of real-world evidence that will be required to conform with the new regulations.

For a consultation on how your organisation can efficiently adapt to the new European regulatory requirements and seize a commercial advantage that may emerge, schedule a meeting with ICON’s Medical Device and Diagnostic Research group leaders at ICONplc.com/devices.

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union, May 5, 2017.