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| Laws | Medical Devices Law (no longer valid)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!
This article will help you ensure that you will still be able to offer in-house IVD (also called Laboratory Developed Tests, LDTs) under the IVDR and will explain the three options open to you avoiding legal disputes. In-house IVD are a type of in vitro diagnostic test. But do regulatory requirements such as the IVDR also…
DetailsAn FDA registration is a legally required registration of “establishments” (such as medical device manufacturers) in an FDA database. The FDA registration should not be confused with the UDI registration in the GUDID database or even an FDA approval. This article answers the most important questions and helps to avoid the most common mistakes in FDA registrations.…
DetailsIn this article you will learn, 1. Contents of a declaration of conformity Annex IV of the MDR specifies what a declaration of conformity must contain: 2. Scope of a declaration of conformity Don’t declare conformity for an unspecified number of devices. Wording that doesn’t contain any restrictions in terms of applicability does not comply with…
DetailsMost manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. This also applies to medical device manufacturers, for example. 1. Standards and harmonized standards a) Definitions and more EU Regulation 1025/2012 defines the term harmonized standard. Standards are documents written by national or international standardization commissions…
DetailsClinical affairs managers play an essential role in demonstrating the safety, performance, and benefits of a medical device. They operate at the interface between science and regulation. This article sheds light on the multifaceted role of these experts: tasks and challenges, as well as earning and career opportunities. 1. Tasks of clinical affairs managers Clinical…
DetailsDocument control is a documented procedure that specifies how documents are created, reviewed, approved, labeled, distributed, and updated. Organizations certified according to ISO 9001 or ISO 13485 are obliged to document control. 1. Subject matter of document control It is obvious that document control is about documents. What is less obvious is what documents are.…
DetailsPDMS stands for patient data management system. These clinical information systems are typically used in hospitals, especially in departments that treat patients in intensive care. PMDS are experiencing a new boom in Germany as a result of the funding provided by the Hospital Future Act (Krankenhaus-Zukunftsgesetz, KHZG). This article provides 1. PMDS: Functionalities and requirements Patient data management systems (PDMS)…
DetailsCompanies need to master the digital transformation quickly and successfully. This also applies to medical device manufacturers because, after all, their future depends on it. Many companies make severe mistakes during this transformation (see section 4). This article provides managers with a quick overview of the possibilities of digital transformation and gives seven tips to make it…
DetailsThis article outlines the five most common misconceptions and mistakes medical device manufacturers should avoid during clinical evaluation and how to avoid them. The five most common misconceptions Misconception 1: A class I device does not require a clinical evaluation This is wrong. All medical devices must meet the essential requirements of the MDR (formerly…
DetailsMedical device manufacturers are obliged to systematically collect and evaluate clinical data, both before and after the approval of their products. The EU Medical Device Regulation (MDR) has increased the requirements for the scope and quality of the required clinical data. This article provides you with an overview of the regulatory requirements and gives tips…
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