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| Laws | Medical Devices Law (no longer valid)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 and as commodity/trade goods |
| 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 |
There are several expert articles on regulatory roles:
| 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 |
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.
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!
Is there a duty for medical device manufacturers for validating ChatGPT and other LLMs that they use in the development, production, approval, and monitoring of their products? If so, how can this be achieved with models that deliver non-deterministic results? This technical article provides answers to these questions and to the question of what your…
DetailsManufacturers who use machine learning (ML) in their medical devices or IVDs must comply with numerous regulatory requirements. This article provides an overview of the most important regulations and best practices for implementation. It saves you the trouble of researching and reading hundreds of pages and helps you prepare perfectly for your next audit.
DetailsThe EU AI Act has been published. Many manufacturers of medical devices and IVD, as well as other healthcare players, are faced with the major task of understanding the 140+ pages of legal text and complying with the requirements. Note: Infringements/violations of the AI Act are punishable by a fine of up to 7% of…
DetailsWith 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.
DetailsWe frequently get asked, “Do you also offer Computerized Systems Validation?” One of the reasons for the interest is certainly: Authorities and notified bodies increasingly address the Computerized Systems Validation (CSV) in audits. This article introduces regulatory requirements regarding “Computerized Systems Validation” and provides guidance on how you can best meet these requirements.
DetailsThe classification of in-vitro diagnostics (IVD) can have far-reaching consequences, as it has an impact on the conformity assessment procedure, certification audits, and, thus, on market launch. To help you prevent the unnecessary allocation of your IVD product to a high-risk class, this article provides an overview of
DetailsThe correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the connection between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…
DetailsLegal Requirements and Practical Implementation under MDR/IVDR EU Authorized Representatives are not only subject to the legal requirements of the MDR and IVDR. They are also liable for violations of medical device law. This expert article provides practical answers to all regulatory questions relating to the EU-REP with specific recommendations for action from the leading consulting firm for…
DetailsThe EU Data Act came into force in December 2023. It aims to create a new legal framework for handling data that will not only affect US tech giants. The EU Data Act will have an impact on many companies that process data, including medical device manufacturers. This article will help you assess:
DetailsTrade 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.
