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Medical Devices Law (no longer valid)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.
4. Authorities, institutions, and associations
a) Germany
b) Europe
c) International
IMDRF: International Medical Device Regulators Forum |
5. Regulatory affairs: Further topics
Here, you will find an article on the tasks and competencies of regulatory affairs managers.
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.
Do you need support?
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The EU regulations place high requirements on the so-called placing on the market of medical devices. Find out in this article what these regulations mean by placing on the market, what misunderstandings and contradictions you must be aware of, and what requirements manufacturers and devices must meet. 1. Placing on the market: Basics a) Definition…
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Software as Medical Device (SaMD) refers to (independent) standalone software that is a medical device but not part of one. It should not be confused with Medical Device Software as defined by the EU. As a manufacturer, when do you have to qualify Software as Medical Device, and when as Medical Device Software? Find out…
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Defining the regulatory strategy is one of the central tasks of the regulatory affairs departments at medical device manufacturers. Why is a good regulatory strategy so important? What do regulatory affairs experts need to do? This article provides the answers. 1. What does a regulatory strategy determine? a) Background Manufacturers of medical devices must comply…
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MDCG published guideline MDCG 2023-4 in October 2023 entitled “Medical Device Software (MDSW) – Hardware combinations – Guidance on MDSW intended to work in combination with hardware or hardware components.” Criticism 1: Unclear scope of MDCG 2023-4 The title gives the impression that (all) types of combinations of hardware and Medical Device Software (MDSW) are…
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How to meet PMCF regulatory requirements as quickly as possible Post-Market Clinical Follow-up is increasingly being criticized by the notified bodies. And this is after the manufacturers have successfully mastered the hurdle before: the initial clinical evaluation. This article provides manufacturers of medical devices with 1. PMCF: The basics a) Objective and definition The MDR…
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Medical devices are increasingly based on closed-loop systems. “Closed-loop systems” are also mentioned in the Medical Device Regulation (MDR). In this article you will learn what closed-loop systems are, where they are used in medicine, and what regulatory requirements they need to meet. The article also reveals how you can save several hundred euros buying the…
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The term “predicate device” most often comes up in the context of FDA 510(k) clearances. However, the FDA does not define this term. It does, however, define what “substantial equivalence” is. Sounds complicated? Demonstrating equivalence is by no means only relevant in the FDA context. That’s why this article provides clarity – especially but not…
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510(k) clearance is the primary procedure for obtaining marketing clearance in the United States. It is also referred to as Premarket Notification (PMN). This article provides a quick overview of the procedure and the documents that must be submitted. 1. General information on the 510(k) clearance by the FDA In contrast to the European jurisdiction…
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For manufacturers, the answer to whether and when clinical studies are necessary when using artificial intelligence in medical devices is relevant. After all, the duration and cost of bringing these devices to market depend on this. The good news in advance: there are cases where manufacturers can avoid clinical studies for devices with AI. This…
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The classification of whether a device is a medicinal product or a substance-based medical device has far-reaching regulatory consequences. This classification is so demanding that there are regular disputes with authorities and notified bodies, and in 2023, even the European Court of Justice had to rule on the matter. This article helps manufacturers, authorities, and…
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