In this edition of the Weekly Compliance Digest, we cover two new regulations in the European Union (EU) on medical devices.
Regulations on Medical Devices and In-Vitro Diagnostic Medical Devices
What is it?
On April 5, 2017, the European Parliament passed two regulations on medical devices that aim to ensure better protection of public health and patient safety by making sure that all medical devices are safe and perform well. The new regulations on medical and in-vitro diagnostic medical devices were first proposed by the European Commission in 2012. To ensure harmonized application of the rules throughout the EU, the two new regulations will replace the three existing Directives on medical devices.
The new rules aim to improve market surveillance and traceability, as well as provide more transparency and legal certainty for producers, manufacturers and importers.
There are over 500,000 types of medical devices and in-vitro diagnostic medical devices in the EU today. Examples of medical devices include contact lenses, x-ray machines, pacemakers, hip replacements and sticking plasters. Examples of in-vitro diagnostic medical devices, which are used to perform tests on samples, include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.
Who is affected?
The new rules affect manufacturers and importers that place medical devices, in-vitro diagnostic medical devices and their accessories on the EU market. Under the new regulations, medical devices and in-vitro diagnostic medical devices are divided into four risk classes. Depending on the risk class of the product, a different conformity assessment procedure may apply before the product can be placed on the EU market. In case of medium- or high-risk classes, Notified Bodies might be involved in the process.
What are the provisions?
Here is a summary of the main provisions of the two new regulations:
- Stricter pre-market control for high-risk devices, such as implants. Certain aesthetic devices (such as colored contact lenses or equipment for liposuction) presenting high-risk to consumers and practices such as reprocessing of single-use devices are included in the scope of the new regulations and made subject to a stricter and more harmonized regime. Rules on clinical evaluation and clinical investigation (and, for in-vitro diagnostic medical devices, performance studies) are generally strengthened and stricter requirements on the use of hazardous substances are introduced.
- A dedicated classification rule for devices incorporating or consisting of nanomaterials. The critical factor is the potential for nanomaterials to be in contact with membranes inside the body. Devices presenting a high or medium potential for such contact will fall under the highest risk class and thus be subject to the most stringent conformity assessment procedures.
- A comprehensive EU database on medical devices (EUDAMED) that will contain a “living picture” of the lifecycle of all products being available in the EU. A large part of the information will be publicly available, including a newly introduced summary of safety and performance for all Class III and implantable devices. The Commission is required to set up the database by spring 2020 and to maintain it thereafter.
- Once devices are available for use on the EU market, manufacturers will be obliged to collect data about their performance.
- Clinical trials taking place in more than one EU Member State will be subject to a single coordinated assessment.
- A simplified procedure allowing manufacturers to register their device only once at the EU level.
- A new device identification system based on a unique device identifier (UDI) that will allow easier traceability of medical devices.
- An “implant card” for patients containing information about implanted medical devices that will make information easily available and accessible.
- A financial mechanism to ensure patients are compensated in case they receive defective products. Manufacturers will be required to have measures in place to provide sufficient financial coverage in respect of their potential liability. The financial coverage will be proportional to the risk class, type of device and the size of the company.
What is next?
The two new rules will be published in the EU’s Official Journal. The regulation on medical devices will start to apply 3 years after publication, while the regulation on in-vitro diagnostic medical devices will start to apply 5 years after publication. New requirements on Notified Bodies and the provisions of the new governance structure will already be applicable six months after the adoption, therefore by the end of this year.
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