SBS - The Best Value in QMS software

Is this a single integral drug device combination product EU MDR

#1
Hello,

I would like your thoughts on whether or not a currently marketed product that is regulated under the medicinal products directive. The product is a drug solution in an IV bag, the bag also has a vial adaptor to introduce additional drugs. Currently the bag is considered a container closure system and we plan to make some minor modifications to the adaptor. Could the bag with the vial adaptor be considered a medical device per rule 2 of MDR? the bag itself is intended to be connected to an IV line for administration.

thanks,

NJin189
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
Classification rules do not define whether something is a device. They define the class of your device (when you already know your item is a device). Perhaps the wording below also helps:

Chapter I, Article 1,

9.Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product. However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.
 
Thread starter Similar threads Forum Replies Date
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
R CND nomenclature for single use instruments CE Marking (Conformité Européene) / CB Scheme 1
P Violation of CE mark - Re-use of single-use Products CE Marking (Conformité Européene) / CB Scheme 2
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
D SINGLE FAULT CONDITION, short circuit and open circuit of any component (IEC 60601-1 3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D Partial FAI - AS9102 - One single drawing has 10 part numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Sidney Vianna Informational IAF and ILAC Seek Contractor for Establishment of a Single International Organization for Accreditation ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
D How to get EUDAMED Single Registration Number (SRN) EU Medical Device Regulations 19
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
M Informational EU draft act – Single-use medical devices – safety and performance requirements for reprocessing Medical Device and FDA Regulations and Standards News 0
Q IATF rule for single site - Ingots from scrap metal recycling company IATF 16949 - Automotive Quality Systems Standard 0
R Supplier Controls we can place on Single-Source Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 2
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 17
A Touch current in single fault conditions test and earth leakage current in normal conditions test, are they really different tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
Ed Panek Can a single supplier fit two or more categories for risk? ISO 13485:2016 - Medical Device Quality Management Systems 2
T No Defined Shelf Life/Expiration Date - Disposable single-use, non-invasive, non-sterile Other Medical Device Regulations World-Wide 2
F Reprocessing or refurbishing? Single Use Medical Device CE Marking (Conformité Européene) / CB Scheme 0
S How to make Single Sign On (SSO) Comply e-sig requirements? ISO 13485:2016 - Medical Device Quality Management Systems 4
E Sample size for design verification of variable in single use device Design and Development of Products and Processes 20
Ed Panek Sensitive Supplier Issue - Single source supplier ISO 13485:2016 - Medical Device Quality Management Systems 6
G Single DFU for multiple medical devices in one box Other Medical Device Regulations World-Wide 0
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
A ISO 2859 Single Sampling - Clarification regarding the sampling table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
bio_subbu Indian government issues guidance on Grouping Medical Devices in a Single Submission Other Medical Device Regulations World-Wide 1
F Marketing a single medical device with multiple indications Other US Medical Device Regulations 4
G IEC 61010 - Single Fault Condition - Protective Impedance Implementation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Definition Sole source VS. Single Source - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
Edward Reesor MDSAP (Medical Device Single Audit Program) Costs Canada Medical Device Regulations 7
Mikey324 GR&R - Little to no part to part variation in single part number Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 14
R How many Corrective Action Request can be Issued by DCMA for a single issue? Nonconformance and Corrective Action 2
I Label Expiration Date - Single Use Combination Medical Device EU Medical Device Regulations 2
M What are Single Fault Conditions and how to test - IEC 80601-2-13 Other Medical Device Related Standards 0
M Merge Technical File, DMR, and Device File into a single document? Other Medical Device and Orthopedic Related Topics 3
P Single Use Disposable Dental Syringe - CE Marking Advice EU Medical Device Regulations 4
S IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E Single Fault Condition Simulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Reliability Testing of a Single-Use (Disposable) Medical Device Reliability Analysis - Predictions, Testing and Standards 4
R Standards Specific to Single Channel ECG Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Ronen E FDA encourages industry to participate in Medical Device Single Audit Program (MDSAP) Other US Medical Device Regulations 10
J QMS and ISO 9001 for a Single Person Machine Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
P Question related to Single Fault Conditions IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Single Point Contact / DoC CE Marking (Conformité Européene) / CB Scheme 2
R How to combine ISO 9001:2015 and ISO 29001:2010 into a single QMS Quality Manager and Management Related Issues 3

Similar threads

Top Bottom