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:
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
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.
Refer also to the article on regulatory affairs managers’ tasks, competencies, and earning potential. This includes the task of developing a regulatory strategy.
| Laws | Medical Devices Law (no longer valid)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) |
| EU directives (only for existing devices) | Medical Device Directive (MDD, 93/42/EEC) and its essential requirements |
| EU regulations | Medical Device Regulation MDR
In-Vitro Diagnostics Regulation (IVDR) General Data Protection Regulation (GDPR) AI Regulation (planned) EU AI Act |
| EU guidelines | Overview of MDCG documents
Examples
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| Harmonized standards | Overview of harmonized standards. You will find further articles on specific standards and their implementation (also) in these categories:
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| Laws | Food, Drug & Cosmetic Act (FD&C)
Administrative Laws (21 CFR)
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| General information | Request for Information: How the FDA helps with classification
FDA eCopy Program FDA Warning Letters and FDA Form 483 (Form 483) Software Change: What the FDA expects from you |
| Approval procedure | FDA updates “Refuse to Accept Policy” for 510(k)
The FDA Pre-Submission Program The FDA Software Precertification (Pre-Cert) Pilot Program FDA’s De Novo Program Level of Concern: What the FDA wants to achieve with this program Special 510(k): When the FDA will allow this “shortcut” Breakthrough Devices Program of the FDA |
| Requirements | FDA Human Factors Guidances
The FDA QSIT: Quality System Inspection Technique The FDA Benefit-Risk Guidance Recognized Consensus Standards of the FDA Guidance ‘Interoperable Medical Devices’ |
| see section 3.a) |
| Approval of medical devices (overview) Please also note the presentation describing the path to the CE mark as well as the articles “7 steps to a medical device” and “Approval of IVDs.“ |
| Conformity assessment procedure (assessing conformity with statutory requirements) |
| Approval in China |
| Approval China FDA / NMPA |
| Approval in Brazil |
| Approval in Japan |
| Approval Saudi Arabia (SFDA) |
| Approval South Korea |
Find more information on international approval
| Qualification as a medical device (medical device yes/no). This also includes the distinction between medicinal products and medical devices, as well as the special case of combination products. |
| Classification according to MDR Class I, IIa, IIb, III or IVDR Class A, B, C and D |
| Qualification and classification of software as a medical device |
| Classification of devices as accessories |
| Technical documentation (overview) |
| Intended purpose (the foundation document) |
| Instructions for use |
| Clinical evaluation of medical devices according to MEDDEV 2.7/1 rev. 4 |
| Risk management files: risk policy, risk management plan, risk analysis, risk management report |
| Usability file |
| Software file, e.g., software requirements specification, software architecture, software tests, software release. Please also note the special features of medical apps (mobile medical apps). |
| Verification and validation of medical devices |
| Unique Device Identification |
Quality management is not usually the responsibility of regulatory affairs. Nevertheless, we have listed some important articles for you.
| Steps to a certified QM system |
| Audits (especially of quality management systems) |
| Systems for Post-Market Surveillance and PMCF (Post-Market Clinical Follow-up) and vigilance |
| Federal Institute for Drugs and Medical Devices (BfArM – Bundesamt für Arzneimittel und Medizinprodukte) |
| German Institute for Medical Informatics (DIMDI – Deutsches Institut für medizinische Informatik); has since been integrated into the BfArM |
| DAkkS, the German accreditation body |
| State authorities: Regional councils, trade supervisory offices, governments |
| Notified bodies |
| NBOG: Notified Body Operations Group |
| MDCG: Medical Device Coordination Group |
| IMDRF: International Medical Device Regulators Forum |
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 still have questions, for example, about the approval of your devices? Then, take advantage of our free micro-consulting service.
If you would like support in developing and “approving” your medical devices in compliance with the law, contact us right away. The Johner Institute team will be happy to help!
Manufacturers of (most) class III medical devices have to undergo the Premarket Approval (PMA) procedure. That is one of the FDA’s most complex submission pathways, with a typical processing time of more than one year. The FDA usually approves only a few dozen PMA applications per year. This article presents the FDA’s requirements and tips…
DetailsWith the UDI system, the EU has introduced an obligation to identify and register medical devices that goes far beyond what is still required under the MDD. The Medical Device Regulation (MDR) even requires a UDI for standalone software. Read about what you need to prepare for here.
DetailsThis article tells you which regulatory requirements you must fulfill, how a vigilance system differs from a system for post-market surveillance, and how you can set up and operate a vigilance system quickly and in compliance with the law.
Manufacturers who wish to place medical devices on the market in the EU must comply with the European Medical Device Regulation MDR. This Regulation (EU) 2017/745 on Medical Devices, as it is officially titled, also imposes requirements on notified bodies, distributors, importers, and health institutions such as hospitals.
DetailsIn this article you will learn,
The DAkkS, the German Accreditation Body, is Germany’s national accreditation authority.
A declaration of interest is a formal document designed to make potential conflicts of interest transparent. Individuals submit a declaration of interest to demonstrate their objectivity and independence. This article is about declarations of interest in a clinical context.
DetailsThe incorporation of AI in medical devices has made great strides, for example, in the diagnosis of disease. Manufacturers of devices with machine learning face the challenge of having to demonstrate compliance of their devices with the regulations. Even if you know the law – what are the standards and best practices to consider in…
DetailsMore and more medical devices are using artificial intelligence e.g., to diagnose patients more precisely and to treat them more effectively.
Medical devices are increasingly based on closed-loop systems. These “closed-loop systems” are already mentioned in the Medical Device Regulation (MDR). One example is a system consisting of an insulin pump controlled by a device with a glucose sensor. In this article, you will learn what closed-loop systems are, where they are used in medicine, and what…
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