What you need to know about developing healthcare solutions and medical devices
Safe and reliable products
If you are a start-up or an established company developing new solutions, understanding and meeting regulatory requirements is essential. Strict safety and performance requirements ensure that your product works as intended and does not put patients at risk. As a general rule, the manufacturer is legally responsible for ensuring that medical devices are safe and secure. Failure to comply with regulatory requirements may result in fines, product recalls and legal disputes.
There are several good reasons to explore regulatory requirements as early as possible:
- Avoid delays and additional costs: meeting regulatory requirements early can prevent time-consuming and costly product adaptations later in the commercialisation process.
- Investors and business partners: confidence in the product's safety and effectiveness is essential to attract investors and business partners.
- Market access: to sell medical devices in Norway and the EEA, your products must bear the CE marking. The CE marking confirms that your product meets all relevant safety and performance requirements. Regulatory requirements are essential for accessing not only the EU market, but international markets too. Many countries have similar requirements, and by meeting EU requirements, your company is well positioned to meet those of other markets as well.
How to proceed
The manufacturer is responsible for determining whether the device qualifies as a medical device. If the answer is yes, the next step is to determine the device's risk class. Depending on the device's risk class, the manufacturer must either carry out the conformity assessment independently or engage a notified body. Notified bodies are designated by the Norwegian authorities and considered competent and capable of assessing whether a product complies with the regulatory safety requirements.
The conformity assessment must result in a declaration of conformity, in which the manufacturer confirms in writing that the device meets the relevant regulatory requirements. CE marking is affixed to the device to indicate this.
Please note that some types of medical devices are subject to specific guidelines or legal provisions, including products without an intended medical purpose and custom-made devices.
Manufacturers of medical devices must have a post-market surveillance system in place once the device has been placed on the market. The system must collect data on the device's quality, safety and performance throughout its lifetime. This data must enable the manufacturer to identify and implement preventive and corrective measures.
Medical devices with artificial intelligence
The development of medical devices that use artificial intelligence is increasing rapidly. AI models developed and used as part of healthcare provision may fall within the definition of a medical device and must therefore meet the requirements of the medical device regulations.
Guidance on regulatory requirements
The Norwegian Medical Products Agency (DMP) is the competent regulatory and supervisory authority for medical device legislation. It provides guidance to and supervises manufacturers, distributors, importers, authorised representatives and notified bodies in Norway.
DMP's advisory responsibilities include requirements for clinical investigations/performance studies, conformity assessment, classification, labelling, information and advertising. DMP also provides guidance on registration, incident reporting, corrective action and the traceability of medical devices under the product regulations.
Please note that the Norwegian Medical Products Agency (DMP) does not provide guidance on the technical details or on how to design a specific clinical investigation. Some of the in-depth expertise in medical device technology lies with the notified bodies.
Useful links
- Medical Devices – Regulatory (NorTrails)
- Webinars on medical devices (Norwegian Medical Products Agency)
- Regulatory (Norway Health Tech)
- EU regulations for health technology – what role do standards play? (Standards Norway)
- Requirements and approvals for health technology (Norwegian Directorate of Health)