What is an MDCG guidance document?

MDCG (Medical Device Coordination Group) guidance documents are non-binding technical guidance published by the European Commission to assist manufacturers, Notified Bodies, and competent authorities in implementing EU MDR 2017/745 and EU IVDR 2017/746. They cover clinical evaluation, post-market surveillance, UDI, EUDAMED, and other compliance topics.

What FDA guidance documents are required for a 510(k) submission?

FDA 510(k) submissions must follow applicable FDA guidance documents including the general 510(k) Guidance, device-specific guidances, and quality system regulation (21 CFR Part 820). Key documents include guidance on substantial equivalence determinations, cybersecurity pre-market requirements, and device-type-specific performance standards.

What is a Team NB document?

Team NB (Team of Notified Bodies) publishes position papers, recommendations, and guidance documents developed collaboratively by European Notified Bodies designated under EU MDR and IVDR. These documents clarify application of regulatory requirements and support harmonised conformity assessment practices across Notified Bodies.

What clinical guidelines are available on Medical Device Navigator?

Medical Device Navigator provides access to 700+ clinical guidelines and recommendations from major European and American medical societies including ESC, ESMO, EULAR, AHA/ACC, ASCO, ADA, NICE, and many more. Guidelines are organized by specialty and geographic scope (European vs American) to help medical device professionals understand clinical practice standards relevant to their devices.

Standards Archives

To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.

Functional Always active

The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.

Preferences

The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.

Statistics

The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.

Marketing

The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.

Standards

ISO 10993-12:2012 — Biological evaluation — Part 12: Sample preparation and reference materials

ISO 10993-18:2020 — Biological evaluation — Part 18: Chemical characterization of medical device materials

ISO 11139:2018 — Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards

ISO 10993-7:2008 — Biological evaluation — Part 7: Ethylene oxide sterilization residuals

ISO 17664-1:2021 — Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

ISO 13408-1:2008/AMD1:2013 — Aseptic processing of health care products — Part 1: General requirements

ISO 14937:2009 — Sterilization of health care products — General requirements for characterization of a sterilizing agent

ISO 5840-1:2021 — Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

ISO 14644-1:2015 — Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

ISO 22442-3:2007 — Medical devices utilizing animal tissues — Part 3: Validation of the elimination and/or inactivation of viruses and TSE agents

ISO 14630:2012 — Non-active surgical implants — General requirements

ISO 20417:2021 — Medical devices — Information to be supplied by the manufacturer

ISO 22442-1:2020 — Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

ISO 17665-1:2006 — Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control

ISO 15223-1:2021 — Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

ISO 11607-2:2019 — Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

ISO 11737-1:2018 — Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

ISO 11137-2:2013/AMD1:2023 — Sterilization — Radiation — Part 2: Establishing the sterilization dose

ISO 11607-1:2019 — Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11137-1:2006/AMD2:2023 — Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control

IEC 60601-1-11:2015/AMD1:2020 — Medical electrical equipment — Part 1-11: Requirements for medical electrical equipment used in the home healthcare environment

ISO 11135:2014 — Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control

IEC 60601-1-6:2010/AMD2:2020 — Medical electrical equipment — Part 1-6: Collateral standard: Usability

IEC 60601-1-8:2006/AMD2:2020 — Medical electrical equipment — Part 1-8: General requirements — Alarm systems

Medical Device Navigator

Directory

Company

Content