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.

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Laws	Medical Devices Law (no longer valid) Medical Devices Implementation Act MPDG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 MDCG 2019-11 (qualification and classification of software, class I software) MDCG documents on legacy devices MDCG 2020-6: Requirements for clinical data for legacy devices MDCG documents on transition periods for the MDR and IVDR MDCG 2020-3 on the main design changes
Harmonized standards	Overview of harmonized standards. You will find further articles on specific standards and their implementation (also) in these categories: Software Development and IEC 62304 Usability Engineering and IEC 62366 Risk Management and ISO 14971 Quality Management Systems and ISO 13485 System Development, including safety requirements (e.g., electrical safety) and IEC 60601-1 (PEMS) and IEC 61010-1 (IVD), as well as biocompatibility (ISO 10993)

c) USA

Laws	Food, Drug & Cosmetic Act (FD&C) Administrative Laws (21 CFR) 21 CFR part 820 (Quality Systems Regulations) 21 CFR part 11 (Computerized Systems Validation)
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 and as commodity/trade goods

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

e) Regulatory Roles

There are several expert articles on regulatory roles:

• EU-Representative (EU-REP)
• Person responsible for regulatory compliance (PRRC)
• Quality management representative / deputy
• Regulatory Affairs manager
• Distributor
• Importer

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

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.