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| Laws | Medical Devices Law (no longer valid)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!
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.
DetailsThe 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…
DetailsWith 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…
DetailsIt is not easy to get medical devices approved in Brazil. This is due to the number of regulations, their complexity, and the fact that Brazil has published most of the regulations in Portuguese only. This article provides an overview and highlights similarities with the European and US systems. This will make it easier for you…
DetailsThe De Novo request, which the FDA also refers to as the “De Novo program” and the “De Novo submission process”, is one of the approval processes for medical devices in the United States. As the name “De Novo” suggests, manufacturers can use this process for novel products. In other words, manufacturers should submit a…
DetailsIn Article 120-123, the MDR establishes its transitional provisions, including the transition periods. However, the descriptions of these transitional provisions and transition periods are worded in a very complex manner. As a result, manufacturers are at risk of misunderstanding them and therefore not complying with regulatory requirements or incurring unnecessary costs. A flow chart in chapter 2 of this article…
DetailsManufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic procedures. This enables them to avoid the time-consuming and costly documentation required for conformity-assessed in vitro diagnostic medical devices (CE-IVDs). Nevertheless, some medical laboratories still use RUO products in diagnostic procedures, sometimes even with the knowledge…
DetailsOne assumption persists: Products for general laboratory use such as PCR cyclers, NGS devices, fragment analyzers, centrifuges, pipetting robots, and extraction kits must bear a CE-IVD marking. Is this correct?
