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.

Regulatory Affairs und Zulassung

Content

On this page, you will find articles on the following topics:

  1. What regulatory affairs is
  2. Regulatory requirements
  3. Authorization and documentation
  4. Authorities, institutions, and associations
  5. 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Laws Medical Devices Law (no longer valid)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

EU directives (only for existing devices) Medical Device Directive (MDD, 93/42/EEC) and its essential requirements

In-vitro Diagnostic Directive (IVD, 98/79/EC)

Radio Equipment Directive RED

EU regulations Medical Device Regulation MDR

In-Vitro Diagnostics Regulation (IVDR)

General Data Protection Regulation (GDPR)

AI Regulation (planned)

PFAS Regulation (planned)

EU Battery Regulation

EU Data Act

EU AI Act

EU guidelines Overview of MDCG documents

Examples

Harmonized standards Overview of harmonized standards. You will find further articles on specific standards and their implementation (also) in these categories:

c) USA

Laws Food, Drug & Cosmetic Act (FD&C)

Administrative Laws (21 CFR)

General information Request for Information: How the FDA helps with classification

FDA eCopy Program

FDA Warning Letters and FDA Form 483 (Form 483)

FDA Inspection

Software Change: What the FDA expects from you

FDA MAUDE Database: Input for risk management

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’

Cybersecurity: FDA guidance documents

Complete overview

d) Other markets

see section 3.a)

3. Approval and documentation

a) Approval

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

b) Qualification and classification (How should my device be classified?)

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

c) Technical documentation (What do I need to document for each device?)

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

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.

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

4. Authorities, institutions, and associations

a) Germany

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

b) Europe

Notified bodies
NBOG: Notified Body Operations Group
MDCG: Medical Device Coordination Group

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.

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!


PICO scheme: The method for systematic and structured literature research 

“Follow the PICO scheme.” This is the recommendation of many auditors and reviewers, as well as some regulatory documents (such as MDCG guidelines and MEDDEV 2.7/1 rev.4), regarding precise medical literature searches.  Read in this article,  1. PICO scheme: The basics  1.1 Definition  The topic is structured according to four aspects:     Aspect  Explanation  P …

Details

Why you should consider clinical studies in Australia 

Conducting clinical studies in Australia is not on the radar of many medical device manufacturers. However, good reasons exist to consider this continent for clinical studies or investigations. Yet manufacturers should also be aware of Australia’s regulatory requirements and specific disadvantages. 1. Advantages and disadvantages of clinical studies in Australia 1.1 Advantages of clinical studies…

Details

Understanding and avoiding deviations and nonconformities

Deviations, nonconformities, errors, findings, observations, and other terms are often used mistakenly synonymously. Even standards explicitly contradict each other when defining individual terms. This article clarifies, 1. Nonconformities: The basics 1.1 Definitions 1.1.1 Nonconformity ISO 9000:2015 defines nonconformity as “non-fulfilment of a requirement.” It equates this term with “error.” ISO 13485 contradicts this. This standard…

Details

MDR transition periods

In Article 120, 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…

Details

Harmonized standards: Evidence for medical device manufacturers

Most 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…

Details

QM document control: How many fail audits

Document 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.…

Details