On May 25, 2016, the various European Union (EU) negotiators have finally reached a deal (four years in the making) on new rules for medical devices and in vitro diagnostic medical devices (see EU press release here). This was unexpected and, although formally there are a couple of further procedural steps, companies active in this space should now assume that the rules are final and will be in force in 2016 (but subject to delayed implementation). In addition to the twenty-eight EU countries, five other countries will be covered by the rules (including Norway, Switzerland, and Turkey).
Currently, the core EU legal framework for medical devices consists of three Directives. The move towards their replacement started on September 26, 2012, when the European Commission (EC) proposed two Regulations which would replace these existing rules: one regarding sales of medical devices and one regarding sales of in vitro diagnostic medical devices. At the time, the EC estimated that around 500,000 different products would be covered, with a sales value (2009) of some EUR95 billion. The target was that the new rules would be adopted in 2014 and come into effect over a period starting from 2015.
Clearly the timetable somewhat slipped, but this was because negotiations proved to be very difficult. Regardless, we now have two new Regulations, which will apply three years after formal publication (later this year) as regards medical devices and five years after formal publication as regards in vitro diagnostic medical devices. All devices sold in the EU will be subject to these rules, so any medical device or in vitro diagnostic medical device manufacturer, supplier or distributor active in the EU needs to be aware of the rules and should start to think about how they would impact its business (many are already doing this).
So what do the new rules do? A lot, but broadly the idea is to strengthen the existing rules on placing devices on the market and establish requirements for follow-up on their quality, performance, and safety (surveillance), with additional checks for high risk devices. In addition, all relevant information on medical devices will be available in central databases.
Here are some specific highlights:
- The rules will further tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market (the so-called “notified bodies”).
- The rules will also give these bodies the right and duty to carry out unannounced factory inspections (this is something that is happening already and companies need to be prepared for this type of “dawn raid”).
- The rules on manufacturers’ responsibilities for follow-up set out clear responsibilities, for instance on liability, but also on registering complaints on devices.
- The rules improve the availability of clinical data on devices. The protection of patients participating in clinical investigations will also be strengthened.
- Controversially, certain high-risk devices, such as implants, may undergo an additional check by experts before they are placed on the market. Also, expert panels and laboratories will play a key role in supporting the legislative system, to provide expertise and guidance on clinical aspects to notified bodies, competent authorities, and to manufacturers.
- Patients who are implanted with a device, will be given key information on the product, including any precautions which might need to be taken.
- Devices will have a unique identification number (UDI) to provide for traceability throughout the supply chain to the end-user or patient.
As mentioned, all companies in the space in the EU need to start preparations if they were not doing so already. It may not seem like it, but time is actually quite tight. For additional background on the rules, please see here.