Regulatory guidance for the development of medical devices

What does NOMA offer?

Being a signatory to the EEA agreement, Norway has the same rights and obligations concerning medical devices as member states of the European Union. Read more about NOMA's role related to medical devices.

NOMA provides regulatory guidance within MDR and IVDR, but not consultancy. This means that we can guide you through the regulations and relevant MDCG guidance documents, but we cannot offer specific solutions for the development of a particular device. Guidance typically pertains to questions about qualification/classification, clinical evaluation/performance evaluation, and clinical investigations/performance studies.

We achieve and maintain our expertise, among other things, through participation in European MDCG working groups. For instance, we participate in groups such as Borderline and Classification (B&C), Clinical Investigation and Evaluation, Performance Studies and Evaluation (CIEPSE), New Technologies (NET), and In Vitro Diagnostic Medical Devices (IVD).

Procedure and timeline for guidance

1. Preparations

Before submitting a request for a guidance meeting, we kindly ask you to familiarize yourself with the available guidance on our website. We specifically refer to the following:

• Development and manufacturing of medical devices
• Qualification and classification of medical devices
• Clinical investigation of medical devices
• Performance studies of in vitro-diagnostic (IVD) medical devices
• Webinars on medical devices (only available in Norwegian)

2. Scheduling a meeting

Fill out the request form titled "Request for scientific and/or regulatory advice". Alternatively, you may send an email to ask-us@noma.no. Please upload a detailed description of the issues as an attachment to help us understand the case and determine the necessary expertise.

The background information should, as a minimum, include:

• A description of the device/study
• Specific questions/topics to be discussed
• Your proposed solutions

Depending on the questions/issues, we may begin with written guidance. Following this, we can determine whether a meeting is appropriate and, if so, its scope.

We may request additional information. Please note that we can provide more tailored guidance if we receive a detailed description of the issue.

NOMA will establish a guidance team and agree on a meeting date with the applicant approximately 5 weeks in advance.

3. Conducting the meeting

We will generally not be open for discussion of other issues in the meeting than those submitted to us beforehand.

The guidance meeting can take place physically at NOMA's office in Oslo (Helsfyr) or virtually via Teams. The meeting duration is a maximum of 60 minutes, unless it has been agreed beforehand that the topic requires more time.

We request that the applicant prepares minutes of the meeting and sends it to us for clarification of any misunderstandings after the meeting has taken place.

Please note that the guidance we provide is based on our current knowledge/understanding of the issue and applicable regulations and guidelines. The guidance and information provided are not binding, neither for NOMA nor for those requesting the guidance.

Request form

Consultation with expert panel (scientific advice)

Manufacturers of certain high-risk medical devices can consult with an expert panel at EMA (European Medicines Agency). This applies to class III medical devices and class IIb active devices intended to administer and/or remove a medicinal product, according to MDR Article 61 (2). The expert panel can provide advice on the manufacturer's planned strategy for clinical development and proposals for clinical investigations. Read more about this on EMA's website: Scientific advice on certain high-risk medical devices.