The “regulatory affairs” section comprises over 200 tasks that need to be completed during the development and approval of medical devices.
Here, you will find an overview of the most essential content so that you can get your device approved quickly.
Content
On this page, you will find articles on the following topics:
- What regulatory affairs is
- Regulatory requirements
- Authorization and documentation
- Authorities, institutions, and associations
- Further topics of regulatory affairs
1. What regulatory affairs is
Regulatory affairs comprises the processes and activities that ensure that medical devices meet the regulatory requirements of the countries where they are sold. This includes
- obtaining the necessary approvals from the regulatory authorities,
- compliance with applicable regulations and standards, and
- maintaining conformity throughout the entire product life cycle until decommissioning.
The tasks of regulatory affairs also include monitoring changes to regulations and standards and communicating these changes to stakeholders within the company to ensure continuous compliance.
Regulatory affairs thus plays a crucial role in ensuring that medical devices are safe, effective, and comply with legal requirements.
Further information
Refer also to the article on regulatory affairs managers’ tasks, competencies, and earning potential. This includes the task of developing a regulatory strategy.
2. Regulatory requirements
a) Germany
| Laws |
Medical Devices Law (no longer valid)
Medical Devices Implementation Act MPDG |
| National regulations |
Medical Device Operator Ordinance (Medizinprodukte-Betreiberverordnung – MPBetreibV)
Medical Device User Notification and Information Ordinance (Medizinprodukte-Anwendermelde- und Informationsverordnung – MPAMIV) |
b) Europe
c) USA
d) Other markets
3. Approval and documentation
a) Approval
Find more information on international approval
b) Qualification and classification (How should my device be classified?)
c) Technical documentation (What do I need to document for each device?)
d) Quality management (What should your company fulfill?)
Quality management is not usually the responsibility of regulatory affairs. Nevertheless, we have listed some important articles for you.
e) Regulatory Roles
There are several expert articles on regulatory roles:
4. Authorities, institutions, and associations
a) Germany
b) Europe
c) International
| IMDRF: International Medical Device Regulators Forum |
5. Regulatory affairs: Further topics
The tasks of Regulatory Affairs also include finding and eliminating deviations and non-conformities. The (emergency) elimination is called remediation.
Note the advantages and disadvantages of Regulatory Information Management Systems (RIMS) and their role in manufacturers’ digital transformation.
Part of the tasks of regulatory affairs is regulatory intelligence.
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Trade goods in the medical device sector can become a regulatory trap for distributors. The line between distributor and manufacturer under the MDR and IVDR is thinner than many people think, with potentially costly legal consequences.