EU Medical Device Regulation (EU MDR)

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

EU General Data Protection Regulation (EU GDPR)

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

Norwegian Laws

• Lov om medisinsk utstyr LOV-2020-05-07-37
• Lov om medisinsk og helsefaglig forskning (helseforskningsloven) LOV-2008-06-20-44

Norwegian Regulations

• Forskrift om håndtering av medisinsk utstyr FOR-2013-11-29-1373
• Forskrift om medisinsk utstyr FOR-2021-05-09-1476
• Forskrift om endring i forskrift om medisinsk utstyr FOR-2023-05-08-674
• Forskrift om organisering av medisinsk og helsefaglig forskning FOR-2009-07-01-955

WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects.

International Organization for Standardization (ISO)

Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)

Addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)

Specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).

Medical devices – Application of risk management to medical devices (ISO 14971:2019)

Specifies terminology, principles and a process for risk management applicable to all phases of the life-cycle of a medical device. Intending to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

Medical Device Coordination Group (MDCG)

The Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector in the European Commission. The group provides advice and draft guidance on its expertise on medical devices.

All its guidance documents are published at the European Commission website: Guidance – MDCG endorsed documents and other guidance.

Guidance on classification of medical devices (MDCG 2021-24)

Provides the purpose of medical device classification, general overview on the impact of the classification, and instructions on how to carry out the classification. Classification principles and rules are described and explained.

Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation (MDCG 2021-6 Rev.1)

Answers to general questions regarding clinical investigation of medical devices, intended for sponsors conducting clinical investigations within the scope of Regulation (EU) 2017/745 (MDR).

Clinical investigation application/notification documents (MDCG 2021-8)

List of clinical investigation documents, with associated templates, required for the application/notification of a clinical investigation within the scope of Regulation EU) 2017/745 (MDR).

Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 (MDCG 2020-10/1 Rev 1)

Guidance on how to perform safety reporting in line with the requirements of the Regulation (EU) 2017/745 (MDR), during clinical investigation of medical devices, or when medical devices are used in clinical trials of medicinal products.

Instructions for generating CIV-IV for MDR Clinical Investigations (MDCG 2021-20)

Instructions on how to generate the European tracking number (CIV-ID), used to identify a specific clinical investigation.

Substantial modification of clinical investigation under Medical Device Regulation (MDCG 2021-28)

Provides a notification form template for use when the clinical investigation intends to introduce modifications that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness of reliability of the clinical data generated by the investigation.

Commission Guidance on the content and structure of the summary of the clinical investigation report (2023/C 163/06)

Guidance to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.

Software

Infographic on New Technologies - Is your software a Medical Device?

Infographic with decision steps to assist qualification of medical device software (MDSW).

Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 - IVDR (MDCG 2019-11)

Defines and gives guidance on the application criteria for the qualification of software falling within the scope of Regulation (EU) 2017/745 (and Regulation (EU) 2017/746).

Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software (MDCG 2020-1)

Provides a framework for the determination of the appropriate level of clinical evidence required for medical device software (MDSW) to fulfil the requirements set out in Regulation (EU) 2017/745 (and Regulation (EU) 2017/746)

European Medicines Agency (EMA)

ICH Guideline for Good Clinical Practice E6(R2)

International ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.