Does an Outside Steam Generator need to be Registered in the EU?

rangani_rj

Involved In Discussions
#1
Hi All,

Do we need to register steam generator as medical device?

Confusion is that some large sterilizers approved in EU have integrated small steam generator but in our case it is placed outside of premises and steam is then transported to sterilizer (small, large, stations). Steam is also used for other purposes, only small part of which is used for sterilizing medical device.

I also found that Pressurized Equipment Directive (PED) is applicable to this unit (as pressure is above 0.5 bar) and it also requires CE marking. Could we use this directive (if MDD is not applicable). Again second question arises here "can we include PED complied device (generator) while showing conformity for MDD device (steam sterilizer)".


I will be grateful who can assist and thanks in advance
 
Elsmar Forum Sponsor
P

pog451

#3
I have no experience with medical devices but I can certainly confirm that your device will be subject to the PED. Don't forget that any piping from the steam generator to your device and other distribution points is also subject to PED.

There should be no problem issuing a CoC to PED and including any declarations of conformity to other directives. It is also perfectly possible for your unit to be subject to two or more directives at once.

If you haven't had much experience with the PED, be aware that CE marking to that directive is not a banal problem. there is also the issue that the ultimate "owner" (and thus CE-marker) of the system will be whoever finally connects it up. If you just supply the generator and piping but it is installed and commissioned by a final user, you may not be the "manufacturer" in the eyes of the PED and and may not be responsible for the CE marking.
 
Thread starter Similar threads Forum Replies Date
T Does your Quality Dept Control Procedures Outside the Scope of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S How often does the FDA inspect organisations outside of the USA? US Food and Drug Administration (FDA) 12
Marc Does your registrar have Specific Requirements outside those of the standard? Registrars and Notified Bodies 90
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 2
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 16
R GS1 DataMatrix code does not meet GS1 Specification EU Medical Device Regulations 0
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
M Does C=0 strictly mean 1 bad, all bad, all the time? ISO 13485:2016 - Medical Device Quality Management Systems 6
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 5
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
M What does "constantly" mean ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How long does it take to register a product with MHRA? UK Medical Device Regulations 14
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom