Following four years of negotiations, the new EU Regulation on Medical Devices (MDR) (Regulation (EU) 2017/745) and Regulation on In Vitro Diagnostics (IVDR) (Regulation (EU) 2017/746) came into effect on 26 May 2017.[a] These regulations apply to a broad range of products – from syringes and bandages to hip replacements and breast implants – and will impose a number of significant changes on device manufacturers in an effort to improve patient safety. Compliance with the new regulations will be mandatory for manufacturers seeking to obtain a CE mark in order to market their products in EU member states. Effective patent protection will become all the more crucial as a way of ensuring first mover advantage for innovative MedTech companies facing increased costs and delays on the route to market.
Among the most notable changes are more stringent clinical requirements and post-marketing surveillance. As a result of the regulations, requirements for clinical trials will be stricter, especially for certain high risk devices. Manufacturers will also be required to provide compensation insurance for trial participants. In addition, device makers will now be required to develop a post-marketing surveillance plan in order to collect performance data for their products, and in certain circumstances will be required to submit various reports on performance to regulators. Devices will also be required to receive unique device identifiers (UDIs), which will be stored in an electronic database and will make it easier to track the performance of a manufacturer’s products.
Another change imposed by MDR and IVDR is greater scrutiny of notified bodies. A competent authority will be appointed in each EU member state to be responsible for reviewing and certifying notified bodies within its jurisdiction, and an appendix to MDR lists the various requirements that each notified body must meet. Furthermore, each body will need to be re-certified on a periodic basis – three years from the date of its first certification under the new regulation, and every four years thereafter – in order to ensure standards are continually maintained.
The new regulations will also impact the risk classifications of certain devices. Currently, devices are classed into one of three categories – class I for devices that are deemed to be low risk, class II for moderate risk devices, and class III for devices that are viewed to possess the highest risk. As a result of MDR and IVDR, certain devices will be moved into a higher class; a notable example is medical smartphone apps, which were previously in class I in most instances but will now potentially be in class II or class III. Because this increase in class will result in increased interactions with notified bodies, costs for app producers are likely to rise. Also, some devices, such as cosmetic contact lenses, that were not covered by the existing legislation are now classified as medical devices under the new regulations.
Although the new regulations became effective on 26 May 2017, a transitional period applies to each of them (until 2020 for MDR, and 2022 for IVDR). During the transition, device manufacturers will be able to opt into the new regime, but may continue to have their products certified under the existing arrangements. At some point in the first half of the next decade, however, the existing regime will fall away entirely, and certificates granted during the transitional period will automatically expire four years after the end of the MDR transition.
While Brexit may limit the impact of these changes in the UK, regardless of where they are based the result for manufacturers marketing in the EU may be increased difficulty in launching products, and increased outlays for research and development, as well as post-market surveillance. This will, in turn, increase the importance of medical device IP, as a tool to help device manufacturers to protect their increased investment in R&D. Furthermore, given the short product life cycle and first mover advantage within the medical device industry, any delays in launching products caused by the new regulations may present significant hurdles for device manufacturers. For device manufacturers, obtaining patent protection at an early stage can help mitigate increased risk and uncertainty.
Despite the delays the new regulations will no doubt cause, unlike pharmaceutical products, generally medical devices do not currently enjoy extension of European patent rights through supplementary protection certificates (SPCs) or data and marketing exclusivity. Coordinated patent filing strategies therefore continue to be important under the new regime. Timing is crucial; too soon and you could cut down the potential period of your monopoly, too late and you may not be able to obtain valid protection at all. Developments in law present you with a moving target too; for example UK case law [b] suggests that confidentiality in clinical trials may not be considered as clear-cut here as elsewhere in Europe.
Considering IP strategy at the outset of a new project, and reviewing it regularly with your investment and exit strategies in mind, can help you to avoid the kinds of errors which can lead to decreased valuations, and even deal breakers, as you develop your business. Find out more here.