Regulatory Updates 2026
Regulatory Update - 457
The following standards have officially been withdrawn. You can now find the newer version of each of them to link to your applicable requirements:
| Withdrawn | Replaced by |
| DIN EN ISO 10993-6:2017-09 | DIN EN ISO 10993-6:2026-08 |
| DIN EN ISO 14155:2021-05; DIN EN ISO 14155/A11:2025-03 | DIN EN ISO 14155:2026-08 |
| DIN EN ISO 14644-14:2017-01 | DIN EN ISO 14644-14:2026-08 |
| DIN EN ISO 14644-13:2017-11 | DIN EN ISO 14644-13:2026-08 |
| DIN EN ISO 14644-15:2018-03 | DIN EN ISO 14644-15:2026-08 |
Regulatory Update - 456
We created a demo entry in the Risk Management Collection for easier tryout.
Regulatory Update - 455
We removed some faulty configurations from the Risk Management Collection.
Regulatory Update - 454
In the Products Collection, you can now find the formfield "Is the IIb device a suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin clip or connector?"
We added the following new standards to our Monitoring:
| Identifier | Name |
| DIN EN ISO 10993-15:2023-07 | Biologische Beurteilung von Medizinprodukten - Teil 15: Qualitativer und quantitativer Nachweis von Abbauprodukten aus Metallen und Legierungen |
| MPAV | Verordnung zur Regelung der Abgabe von Medizinprodukten. |
| MPBetreibV | Verordnung über das Betreiben und Benutzen von Medizinprodukten (Medizinprodukte-Betreiberverordnung - MPBetreibV) |
| Team-NB_2024-04_Position Paper | Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 - Version 4 |
Regulatory Update - 453
We had to perform some technical changes to some of the collection views - none of them resulting in noticeable differences.
Regulatory Update - 452
We had to perform some technical changes to some of the collection views - none of them resulting in noticeable differences.
Regulatory Update - 451
We had to perform some technical changes to some of the collection views - none of them resulting in noticeable differences.
Regulatory Update - 450
We added new standards to the Monitored Requirements. New Standards that we added to our Monitoring:
| Identifier | Name |
| ASTM D4332-22 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| ASTM D4728-17(2022) | Standard Test Method for Random Vibration Testing of Shipping Containers |
| ASTM D5276-19(2023) | Standard Test Method for Drop Test of Loaded Containers by Free Fall |
| ASTM D642-25 | Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads |
| ASTM D999-08(2023) | Standard Test Methods for Vibration Testing of Shipping Containers |
| ASTM E1252-98(2021) | Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis |
| ASTM F1671/F1671M-26 | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
| ASTM F1839-08(2021) | Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| ASTM F2394-07(2022) | Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System |
| ASTM F3127-22 | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
| ASTM F899-23 | Standard Specification for Wrought Stainless Steels for Surgical Instruments |
| DIN 31051:2019-06 | Grundlagen der Instandhaltung |
| DIN EN ISO/IEC 17025:2018 | Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien (ISO/IEC 17025:2017) |
| DIN ISO 22309:2015-11 | Mikrobereichsanalyse - Quantitative Analyse mittels energiedispersiver Spektroskopie (EDS) für Elemente mit der Ordnungszahl 11 (Na) oder höher (ISO 22309:2011) |
| EN ISO 10555-3:2013 | Sterile, single-use intravascular catheters - Part 3: Central venous catheters |
| EN ISO 10555-4:2023 | Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters |
| EN ISO 13402:2025 | Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure |
| EN ISO 25539-1:2017 | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| EN ISO 25539-2:2020 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
| EN ISO 6009:2016 | Hypodermic needles for single use - Colour coding for identification |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods |
| ISO 10555-1:2023 | Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements |
| ISO 10555-4:2023 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters |
| ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process |
| ISO 10993-18:2020/Amd 1:2022 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1 |
| ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| ISO 10993-23:2021/Amd 1:2025 | Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1 |
| ISO 11135:2014 | Sterilization of health-care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11135:2014/Amd 1:2018 | Sterilization of health-care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 |
| ISO 11453:1996 | Statistical interpretation of data - Tests and confidence intervals relating to proportions |
| ISO 11453:1996/Cor 1:1999 | Statistical interpretation of data - Tests and confidence intervals relating to proportions - Technical Corrigendum 1 |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 11607-1:2019/Amd 1:2023 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11607-2:2019/Amd 1:2023 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 |
| ISO 11737-1:2018 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products |
| ISO 11737-1:2018/Amd 1:2021 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 |
| ISO 13402:2025 | Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure |
| ISO 2859-1:2026 | Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection |
| ISO 80369-20:2024 | Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| ISO 80369-7:2021 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
| ISO 8573-1:2010 | Compressed air - Part 1: Contaminants and purity classes |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| ISO/IEC 15416:2025 | Information technology - Automatic identification and data capture techniques - Bar code print quality test specification - Linear symbols |
| ISO/IEC 15418:2016 | Information technology - Automatic identification and data capture techniques - GS1 Application Identifiers and ASC MH10 Data Identifiers and maintenance |
| ISO/IEC 15426-2:2023 | Information technology - Automatic identification and data capture techniques - Bar code verifier conformance specification - Part 2: Two-dimensional symbols |
Regulatory Update - 449
We slightly changed some Document Types - the "Shelf Life Stability" (Annex, Plan, Report, Statement) had an unnecessary - that we removed.
Regulatory Update - 448
Regulatory Status of ASTM F1671/F1671M-25a has been updated to withdrawn. Updated standard has been added in new entry ASTM F1671/F1671M-26.
We added new standards to the Monitored Requirements. New Standards that we added to our Monitoring:
| Identifier | Name |
| ASTM F1671/F1671M-26 | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
| ASTM D642-25 | Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads |
| ASTM F899-23 | Standard Specification for Wrought Stainless Steels for Surgical Instruments |
| ASTM D999-08(2023) | Standard Test Methods for Vibration Testing of Shipping Containers |
| ASTM E1252-98(2021) | Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis |
| ASTM F1839-08(2021) | Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| ASTM F2394-07(2022) | Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System |
| ASTM F3127-22 | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
| ASTM D4332-22 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| ASTM D4728-17(2022) | Standard Test Method for Random Vibration Testing of Shipping Containers |
| ASTM D5276-19(2023) | Standard Test Method for Drop Test of Loaded Containers by Free Fall |
| ISO 2859-1:2026 | Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 2859-1:2026 |
| EN ISO 6009:2016 | Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016) |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| ISO 8573-1:2010 | Compressed air — Part 1: Contaminants and purity classes |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| ISO 10555-1:2023 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| EN ISO 10555-3:2013 | Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013) |
| EN ISO 10555-4:2023 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023) |
| ISO 10555-4:2023 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
| ISO 10993-18:2020/Amd 1:2022 | Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor |
| ISO 10993-18:2020 | Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process |
| ISO 10993-23:2021 | Biological evaluation of medical devices — Part 23: Tests for irritation |
| ISO 10993-23:2021/Amd 1:2025 | Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11135:2014/Amd 1:2018 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release |
| ISO 11453:1996 | Statistical interpretation of data — Tests and confidence intervals relating to proportions |
| ISO 11453:1996/Cor 1:1999 | Statistical interpretation of data — Tests and confidence intervals relating to proportions — Technical Corrigendum 1 |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 11607-1:2019/Amd 1:2023 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11607-2:2019/Amd 1:2023 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management |
| ISO 11737-1:2018 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| ISO 11737-1:2018/Amd 1:2021 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1 |
| EN ISO 13402:2025 | Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:2025) |
| ISO 13402:2025 | Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure |
| ISO/IEC 15416:2025 | Automatic identification and data capture techniques — Bar code print quality test specification — Linear symbols |
| ISO/IEC 15418:2016 | Information technology — Automatic identification and data capture techniques — GS1 Application Identifiers and ASC MH10 Data Identifiers and maintenance |
| ISO/IEC 15426-2:2023 | Information technology — Automatic identification and data capture techniques — Bar code verifier conformance specification — Part 2: Two-dimensional symbols |
| DIN EN ISO/IEC 17025:2018 | Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien (ISO/IEC 17025:2017); Deutsche und Englische Fassung EN ISO/IEC 17025:2017 |
| DIN ISO 22309:2015-11 | Mikrobereichsanalyse - Quantitative Analyse mittels energiedispersiver Spektroskopie (EDS) für Elemente mit der Ordnungszahl 11 (Na) oder höher (ISO 22309:2011) |
| EN ISO 25539-2:2020 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020) |
| EN ISO 25539-1:2017 | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017) |
| DIN 31051:2019-06 | Grundlagen der Instandhaltung |
| ISO 80369-7:2021 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications |
| ISO 80369-20:2024 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
Regulatory Update - 447
To allow more detailed tracking of standards, we have adapted how we present standards in the "Monitored Requirements" Collection.
In the past, you would find only one entry per standard, with new amendmends or new versions overwriting older ones.
From now one, we will distinguish between the different publications. New amendmends or new versions will lead to a new entry, that is linked to the previous versions for traceability.
When linking to these monitored requirements in your list of applied standards, you can now distinguish clearer between the different versions.
New harmonizations have been published by the european union. You can find now, with the status "harmonized" in our Monitored Requirements:
For IVDR
| Identifier | Name |
|---|---|
EN ISO 15223-1:2021 EN ISO 15223-1:2021/A1:2025 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) |
For MDR:
| Identifier | Name |
|---|---|
EN ISO 10993-23:2021 EN ISO 10993-23:2021/A1:2025 | Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) |
EN ISO 10993-12:2021 EN ISO 10993-12:2021/A1:2025 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993 12:2021) |
EN ISO 15223-1:2021/A1:2025 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) |
EN IEC 60601-2-83:2020 EN IEC 60601-2-83:2020/A11:2021 EN IEC 60601-2-83:2020/A1:2025 | Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment |
EN ISO 10993-17:2023 EN ISO 10993-17:2023/A1:2025 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) |
| EN ISO 1135-4:2025 | Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2025) |
| EN ISO 1135-5:2025 | Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2025) |
| EN ISO 10993-1:2025 | Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025) |
EN ISO 10993-5:2009 EN ISO 10993-5:2009/A11:2025 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| EN ISO 12870:2025 | Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2024) |
| EN ISO 14607:2025 | Non-active surgical implants - Mammary implants - Specific requirements (ISO 14607:2024) |
| EN ISO 14889:2025 | Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2025) |
| EN ISO 15883-1:2025 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024) |
| EN ISO 15883-2:2025 | Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO 15883-2:2024) |
| EN ISO 15883-3:2025 | Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2024) |
| EN ISO 15883-7:2025 | Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025) |
| EN ISO 22675:2025 | Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2024) |
| EN ISO 23908:2025 | Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods (ISO 23908:2024) |
EN 60601-1:2006 EN 60601-1:2006/A13:2024 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
Regulatory Update - 446 - Regulatory Update - 426
Will be written up shortly. If you need more detailed information right away, please contact the support.
Regulatory Update - 425
Created new Demo Data Entry in the eCER Collection
Created German eRisk Plan and Report Template
Updated the German language in eCER View, minor updates of old eRisk RMP & RMR templates.
Regulatory Update - 424
Replaced non-functional "Responsibilities and Authorities" Field in Clinical Evaluation Management with new functional field.
Regulatory Update - 423
Updated Collection Entry View in the Products Collection - included the Nanomaterial - Summary formfield
Regulatory Update - 422
We updated old Executive Summary demo document for Infusion Technology to Writer document
We added new standards to the Monitored Requirements. New Standards that we added to our Monitoring:
| Identifier | Name |
|---|---|
| 2001/83/EC | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use |
| ANSI/AAMI ST72:2019 | Bacterial Endotoxin (LAL) Testing |
| ASTM F 756-17(2025) | Standard Practice for Assessment of Hemolytic Properties of Materials |
| ASTM F2503-23e1 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| ASTM F640-23 | Standard Test Methods for Determining Radiopacity for Medical Use |
| DIN 13097-4:2019-06 | Medizinische Kanülen - Teil 4: Anschliffarten, Anforderungen und Prüfung |
| DIN 58953-6:2025-03 | Sterilisation - Sterilgutversorgung - Teil 6: Prüfung der Keimdichtigkeit von Verpackungsmaterialien für zu sterilisierende Medizinprodukte |
| EMA/37991/2019 rev 6 | Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) |
| EMA/CHMP/QWP/BWP/259165/2019 | Guideline on quality documentation for medicinal products when used with a medical device |
| EMEA/CHMP/QWP/49313/2005 | Guideline on the pharmaceutical quality of inhalation and nasal medicinal products |
| EN 17957:2024 | Vapour products - Vaping regime for products intended to be used for direct to lung inhalation |
| EN 60601-1-11:2015;EN 60601-1-11:2015/A1:2021 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| EN 62133-2:2017/A1:2021 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems |
| EN 868-10:2018 | Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods |
| EN 868-5:2018 | Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods |
| EN ISO 10555-1:2023 | Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023) |
| EN ISO 10993-11:2018 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017) |
| EN ISO 10993-7:2008/AC:2009 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009) |
| EN ISO 11070:2014/A1:2018 | Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018) |
| EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| EN ISO 27427:2023 | Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023) |
| EN ISO 80369-1:2018 | Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018) |
| EN ISO 80369-20:2024 | Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369‑20:2024) |
| EN ISO 8536-14:2018 | Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016) |
| EN ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016) |
| IEC 60601-1-2:2014 ED4;IEC 60601-1-2:2014/AMD1:2020 ED4 | Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO 10555-8:2024 | Intravascular catheters — Sterile and single-use catheters Part 8: Catheters for extracorporeal blood treatment |
| ISO 16269-6:2014-01 | Statistical interpretation of data - Part 6: Determination of statistical tolerance intervals |
| ISO 18562-1:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process |
| ISO 18562-2:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter |
| ISO 18562-3:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3: Tests for emissions of volatile organic substances |
| ISO 18562-4:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate |
| ISO 20072:2009 | Aerosol drug delivery device design verification — Requirements and test methods |
| ISO/IEC 7810:2019, ISO/IEC 7810:2019/Amd 1:2024 | Identification cards — Physical characteristics Amendment 1: Additional requirements for integrated circuit cards with contacts |
| ISO/TR 8417:2024 | Risk management of particulate contamination for devices with intravascular access |
Regulatory Update - 421
We updated some of our Demo Data for Infusion Technology to Writer Documents instead of Word Documents
Regulatory Update - 420
New Document Type "Design & Manufacturing Summary", added as optional requirement to IVDR Folder Preview Templates
Created new Declaration of Conformity Templates on eTD Level, updated PG DoC Templates accordingly,
Added new formfield "Nanomaterial - Summary" Editorfield on Product, Productgroup and eTD level (only visible if "contains nanomaterial" is set to yes).
Regulatory Update - 419
In eCER collection, the formfield "Responsibilities and Authorities" is now an editor field instead of a list.
New Document Types "Information to be supplied by the manufacturer" and "State of the Art Analysis", both added as optional requirements to IVDR standard folder preview templates.
Regulatory Update - 418
New Updated Standard: DIN EN ISO 10993-1:2026-03
Added country South Sudan to collection Countries & Regions
Regulatory Update - 417
New harmonizations have been published by the european union. You can find now, with the status "harmonized" in our Monitored Requirements:
For IVDR:
| Identifier | Name |
|---|---|
| EN ISO 18113-1:2024 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022) |
| EN ISO 18113-2:2024 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022) |
| EN ISO 18113-3:2024 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022) |
| EN ISO 18113-4:2024 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022) |
| EN ISO 18113-5:2024 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022) |
| EN ISO 17665:2024 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) |
For MDR:
| Identifier | Name |
|---|---|
| EN ISO 17665:2024 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) |
| EN ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) |
| EN ISO 80369-2:2024 | Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06) |
| EN ISO 21536:2024 | Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023) |
| EN ISO 21535:2024 | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023) |
| EN ISO 18562-1:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024) |
| EN ISO 18562-2:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024) |
| EN ISO 18562-3:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024) |
| EN ISO 18562-4:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024) |
Regulatory Update - 416
We added further new IVDR templates. You can now find ready to use templates for eTD level: Executive Summary. You can now find ready to use templates for product level: Executive Summary, IVDR Classification, Intended Purpose, List of applied Standards. All new templates are available in german and english.
Regulatory Update - 415
We added a new Document Template "Intended Purpose" specifically for IVDR. The scope of the template is on Product level.
We changed our inspections - in the future, if your product is set to the status "in development", the inspector will no longer expect information on "marketed in these countries"
Regulatory Update - 414
We added unique ID fields to the collections "Change Management" and "CAPA Management" to allow for a unique identification of each entry.
We added a new formfield to our eTD datamodel "Is the device directly marked?" - available each on eTD, ProductGroup and Product level
Regulatory Update - 413
We have changed the configuration on all codes (IVP, IVR, IVS, IVT, EMDN, GMDN, JMDN, UMDNS, MD, MDA, MDN, MDS, MDT) to unique. As these codes are saved in collections, no code should ever be twice in those collections.
We added new standard to the Monitored Requirements. New Standards that we added to our Monitoring:
| Identifier | Name |
|---|---|
| EN IEC 60601-2-83:2020/A1:2025 | Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment |
Regulatory Update - 412
We added new standards to the Monitored Requirements. New Standards that we added to our Monitoring:
| Identifier | Name |
|---|---|
| 1272/2008 | Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance) |
| 1907/2006 | erordnung (EG) Nr. 1907/2006 des Europäischen Parlaments und des Rates vom 18. Dezember 2006 zur Registrierung, Bewertung, Zulassung und Beschränkung chemischer Stoffe (REACH), zur Schaffung einer Europäischen Agentur für chemische Stoffe, zur Änderung der Richtlinie 1999/45/EG und zur Aufhebung der Verordnung (EWG) Nr. 793/93 des Rates, der Verordnung (EG) Nr. 1488/94 der Kommission, der Richtlinie 76/769/EWG des Rates sowie der Richtlinien 91/155/EWG, 93/67/EWG, 93/105/EG und 2000/21/EG der Kommission |
| 2010/32/EU | Richtlinie 2010/32/EU des Rates vom 10. Mai 2010 zur Durchführung der von HOSPEEM und EGÖD geschlossenen Rahmenvereinbarung zur Vermeidung von Verletzungen durch scharfe/spitze Instrumente im Krankenhaus- und Gesundheitssektor (Text von Bedeutung für den EWR) |
| 2020/561 | Verordnung (EU) 2020/561 des Europäischen Parlaments und des Rates vom 23. April 2020 zur Änderung der Verordnung (EU) 2017/745 über Medizinprodukte hinsichtlich des Geltungsbeginns einiger ihrer Bestimmungen (Text von Bedeutung für den EWR) |
| 2021/2226 | Durchführungsverordnung (EU) 2021/2226 der Kommission vom 14. Dezember 2021 mit Durchführungsbestimmungen zur Verordnung (EU) 2017/745 des Europäischen Parlaments und des Rates hinsichtlich elektronischer Gebrauchsanweisungen für Medizinprodukte |
| 2023/607 | Verordnung (EU) 2023/607 des Europäischen Parlaments und des Rates vom 15. März 2023 zur Änderung der Verordnungen (EU) 2017/745 und (EU) 2017/746 hinsichtlich der Übergangsbestimmungen für bestimmte Medizinprodukte und In-vitro-Diagnostika (Text von Bedeutung für den EWR) |
| 2024/1860 | Verordnung (EU) 2024/1860 des Europäischen Parlaments und des Rates vom 13. Juni 2024 zur Änderung der Verordnungen (EU) 2017/745 und (EU) 2017/746 hinsichtlich der schrittweisen Einführung von Eudamed, der Informationspflicht im Falle einer Unterbrechung oder Beendigung der Versorgung und der Übergangsbestimmungen für bestimmte In-vitro-Diagnostika (Text von Bedeutung für den EWR) |
| 2024/2853 | Richtlinie (EU) 2024/2853 des Europäischen Parlaments und des Rates vom 23. Oktober 2024 über die Haftung für fehlerhafte Produkte und zur Aufhebung der Richtlinie 85/374/EWG des Rates (Text von Bedeutung für den EWR) |
| 2025/1234 | Durchführungsverordnung (EU) 2025/1234 der Kommission vom 25. Juni 2025 zur Änderung der Durchführungsverordnung (EU) 2021/2226 hinsichtlich der Medizinprodukte, für die die Gebrauchsanweisungen in elektronischer Form bereitgestellt werden können |
| 207/2012 | Verordnung (EU) Nr. 207/2012 der Kommission vom 9. März 2012 über elektronische Gebrauchsanweisungen für Medizinprodukte Text von Bedeutung für den EWR |
| 80/181/EWG | Richtlinie 80/181/EWG des Rates vom 20. Dezember 1979 zur Angleichung der Rechtsvorschriften der Mitgliedstaaten über die Einheiten im Meßwesen und zur Aufhebung der Richtlinie 71/354/EWG |
| 93/42/EWG | Medizinprodukte-Richtlinie 93/42/EWG (Medical Device Directive MDD) |
| 98/79/EG | Richtlinie 98/79/EG des Europäischen Parlaments und des Rates vom 27. Oktober 1998 über In-vitro-Diagnostika |
| CLSI MM17 | Validation and Verification of Multiplex Nucleic Acid Assays |
| CLSI NBS01 | Dried Blood Spot Specimen Collection for Newborn Screening |
| DIN EN 15986:2011-05 | Symbol zur Kennzeichnung von Medizinprodukten - Anforderungen zur Kennzeichnung von phthalathaltigen Medizinprodukten; Deutsche Fassung EN 15986:2011 |
| DIN EN ISO 10993-16:2018-02 | Biologische Beurteilung von Medizinprodukten - Teil 16: Entwurf und Auslegung toxikokinetischer Untersuchungen hinsichtlich Abbauprodukten und herauslösbaren Substanzen (ISO 10993-16:2017); Deutsche Fassung EN ISO 10993-16:2017 |
| DIN EN ISO 18113-2:2024-10 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022) |
| DIN EN ISO 20697:2019-04 | Sterile Drainagekatheter und Zubehör zur einmaligen Verwendung (ISO 20697:2018, korrigierte Fassung 2018-09); Deutsche Fassung EN ISO 20697:2018 |
| DIN EN ISO 80369-6:2025-12 | Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 6: Verbindungsstücke für neurale Anwendungen (ISO 80369-6:2025); Deutsche Fassung EN ISO 80369-6:2025 |
| GHTF/SG1/N063:2011 | Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices |
| GHTF/SG1/N071:2012 | Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ |
| GHTF/SG5/N7:2012 | Clinical Evidence for IVD medical devices – Scientific Validity Determination and Performance Evaluation |
| ISO 10993-17:2023 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents |
| ISO 10993-17:2023/Amd 1:2025 | Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents (Amendment 1) |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| ISO 18113-2:2022-10 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use |
| ISO 24415-2:2011 | Tips for assistive products for walking — Requirements and test methods (Part 2: Durability of tips for crutches) |
| ISO 639:2023-11 | Code for individual languages and language groups |
| IVDR (EU) 2017/746:2025-01 | REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU |
| MDCG 2025-8 | Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles |
| MDCG 2025-9 | Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 |
| MDCG 2025–10 | Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices |
| MFG, Teil I | Medizinforschungsgesetz |
| MPEUAnpG | Medizinprodukte-EU-Anpassungsgesetz – MPEUAnpG |
| MPEUAnpV | Verordnung zur Anpassung des Medizinprodukterechts an die Verordnung (EU) 2017/745 und die Verordnung (EU) 2017/746 |
| TRBA 250 | Biologische Arbeitsstoffe im Gesundheitswesen und in der Wohlfahrtspflege (Technische Regel für Biologische Arbeitsstoffe) |
Regulatory Update - 411
We added EN IEC 80601-2-77 to the monitoring
Regulatory Update - 410
Standard Update!
ISO 10993-1:2018 has been updated to 10993-1:2025
Regulatory Update - 409
We updated the german translation of the MDA/MDN Codes
Last updated: 8/19/26, 6:10 AM