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Medical Devices Law (no longer valid)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.
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With the term eCopy, the FDA refers to the electronic copy/version of paper-based submissions, e.g., as part of a 510(k) submission.
What is a Device Master Record (DMR)? Does software also need a DMR? If so, what are the regulatory requirements in the US and Europe? And what should a DMR contain? This article provides answers.
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A ‘Request for Information’ can (partially) avoid expensive legal fees. Just ask the authorities directly! This way, you will get a qualified answer, even if it is not free of charge. Read here to find out
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Some Medical Device Regulation (MDR) changes affect all medical device manufacturers. Some of these changes are particularly aimed at manufacturers whose products contain software or are standalone software. Read on to find out what these manufacturers should be aware of.
The requirements for clinical investigations to evaluate a device have increased enormously under the MDR. Learn the most important things you need to know about the regulatory pathway for clinical investigations under the MDR here.
Most medical device manufacturers associate the term “design validation” with the FDA. However, not only the FDA but also European regulations, particularly ISO 13485, require design and development validation. Nevertheless, design validation and validation of the design should not be confused. This article shows how the two differ and which regulatory requirements must be observed.
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The Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and inspections by authorities from different countries with one audit. Participating in the MDSAP shall suffice for verifying effectiveness and conformity of QM systems (e.g., with ISO 13485 or 21 CFR part 820). In…
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With the Pre-Submission Program (“pre-sub” for short), the FDA offers a formal procedure for manufacturers to clarify their regulatory strategy and specific questions before actual approval or market clearance. A pre-sub request is suitable in the preparation of 510(k)s, De Novo Requests, or PMAs, among other things. This can avoid unnecessary costs and effort on…
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With the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g., the 510(k) procedure) through digitalization. The Johner Institute is working with the FDA on the further development of eStar. This article tells you how forward-looking this approach is and whether you should or even must take part.
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