Hospital Decontamination and the MDR - Technical Files, UDI and PMS

#1
A trust that I have worked with for some time intends on supplying procedure packs (Article 22) and supplementary items to health clinics and would then be considered as placing devices on the market. We are now unable to use Article 5.5 of the MDR and would be considered as the legal manufacturer. The Trust is ISO13485 accredited and also to Article 12 of the MDD. Can anyone clarify the extent to which the MDR or similar UK adopted regulation, would apply in terms of Technical Files, UDI and PMS? Thanks in advance
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
I don't see a specific requirement for technical files for procedure packs, however, in addition to the statement referred to in Article 22-2, I would suggest a file describing how the requirements of paragraph 2 have been met.

Regarding UDI, take a look at MDR Article 26 para 2 and Annex VI 3.7

2. Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom- made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack.

Also see Annex VI, Para 3.7, and 6.3, and maybe other sections.

I would say, Post Market Surveillance is a given, it should be performed by all manufactures.

If you are a UK hospital trust, you are probably not the only ones facing this problem. Is there a NHS group who can advise?
 

dgrainger

Trusted Information Resource
#3
UK legislation is still based on MDD. This is the only guidance on post Transition period legislation at the moment:
Medical devices: EU regulations for MDR and IVDR


Update on delay to full implementation
The European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU.​
We are taking steps to plan for after the end of the transition period. We will provide guidance on this in due course in light of Government decisions required on the future of UK regulation. All decisions on regulations will be taken with a view to prioritising patient safety and ensuring patient access for medical devices.​
In the meantime, the existing regulatory requirements should continue to be met.​
 
#4
Hi Chris, this is is really helpful
Kind of suggests they will have a lot of work to do in terms of sorting UDI procedures etc, I think that is the bigger challenge than any Tech File stuff.
Unfortunately, I'm not aware of any NHS groups looking at this. Most trusts have decided to stop doing it or are being very quiet about doing it.
 
Thread starter Similar threads Forum Replies Date
F Hospital Rebrand & Name changes Document Control Systems, Procedures, Forms and Templates 4
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O Hospital-Developed, In-House Device - FDA Clearance? Other US Medical Device Regulations 19
A Hospital IT expectations for connected medical device using WIFI Medical Information Technology, Medical Software and Health Informatics 0
K Hospital UDI requirements Other Medical Device and Orthopedic Related Topics 7
M Oxygen enriched environment applicability - Operating table used in general surgeries in hospital IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D How to Calibrate any Digital Sphygmomanometer under use for 2 years in a Hospital Forum News and General Information 1
M Contactless Hospital Bed Sensor Certification IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IVD regulatory requirements for different hospital environments Other Medical Device and Orthopedic Related Topics 1
Q Mexico Medical Device Registration - Private Hospital Exemption Other Medical Device Regulations World-Wide 1
Wes Bucey Hospital Turns Down Malcolm Baldrige National Quality Award World News 0
S Selling a CE Marked Product to a Hospital in Bulgaria Other Medical Device Regulations World-Wide 4
I What is an Ideal Control Chart for Hospital Surgery Infections? FMEA and Control Plans 2
2 Discussion about Hospital Carts Medical Information Technology, Medical Software and Health Informatics 7
S Lean Hospital - Implementing a quality/lean/six sigma program Lean in Manufacturing and Service Industries 3
Ronen E Cybersecurity for Medical Devices and Hospital Networks Medical Information Technology, Medical Software and Health Informatics 1
R EU requirements for Hospital Use Health IT software CE Marking (Conformité Européene) / CB Scheme 2
I Hospital Product/Service Realization and Monitoring/Measurement (ISO 9001) Hospitals, Clinics & other Health Care Providers 4
D ISO 13485 for Hospital Sterilization Departments ISO 13485:2016 - Medical Device Quality Management Systems 2
R Hospital Grade Mains Plug US (NEMA 5-15) and Japan IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L Hospital Laboratory IVD (In Vitro Diagnostic) Transportation Classification in Brazil Other Medical Device Regulations World-Wide 2
R Should be Hospital Grade Plug be used in Class II Medical Equipment? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Posey Bed or Hospital Bed Regulatory Process Japan Medical Device Regulations 1
A Hospital Internal Audit Check List Hospitals, Clinics & other Health Care Providers 5
J Sterilisation Validation of Re-Usable Hospital Instruments ISO 13485:2016 - Medical Device Quality Management Systems 1
B Hospital Operating Room Regulations - Separate Entrances for Clean and Dirty Supplies Hospitals, Clinics & other Health Care Providers 4
B Hospital Wall Mounts (for Display Monitors and other devices) - Requirements Occupational Health & Safety Management Standards 10
J Hospital Laboratory wants to apply ISO 9001 Hospitals, Clinics & other Health Care Providers 10
S ISO 15189 Hospital Laboratory Accreditation - Forms and Templates needed Document Control Systems, Procedures, Forms and Templates 1
T Part 880.5100 AC-powered adjustable Hospital Bed - Applied Parts Marking or Labeling Other US Medical Device Regulations 1
S FCC Rules for Hospital Wireless Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Common Sterilization Methods in Hospital - Prevalence? Hospitals, Clinics & other Health Care Providers 2
V Is a Hospital Grade Power Cord Required? Class I Medical Device Other US Medical Device Regulations 4
somashekar Requirements for Patient Gowning & other Hospital Clothes, sheets wrt. static charge? Other Medical Device Related Standards 2
xcanals_tecno-med.es ISO 13485 in Hospital Central Sterilization and Clinical Engineering Services ISO 13485:2016 - Medical Device Quality Management Systems 27
P Class I & II Rx Medical Devices - Pre-Hospital Market Distribution questions ISO 13485:2016 - Medical Device Quality Management Systems 3
D Best Practices for Safe Handling of Rented Hospital Mattresses Hospitals, Clinics & other Health Care Providers 4
M Risk Management Standards - Hospital Information System (electronic health records) Hospitals, Clinics & other Health Care Providers 4
L Hospital Grade and Medical Grade power cord differences? Hospitals, Clinics & other Health Care Providers 2
Sidney Vianna Ball Memorial Hospital - The first Indiana hospital to receive NIAHO accreditation Hospitals, Clinics & other Health Care Providers 1
S Biocompatibility - Hospital Bed ISO 13485:2016 - Medical Device Quality Management Systems 12
B Identifying Peak Demand and Usage with Start/End Time - Hospital Hospitals, Clinics & other Health Care Providers 3
Sidney Vianna Medicare to Cease Payment for Hospital Error Hospitals, Clinics & other Health Care Providers 0
M Possible thread moves? (To the New Hospital and Health Care Providers forum) Hospitals, Clinics & other Health Care Providers 3
Sidney Vianna New protocol for hospital accreditation: NIAHO. Includes ISO 9001 Hospitals, Clinics & other Health Care Providers 10
J Why document control matters - Hospital or Health Care Environment Hospitals, Clinics & other Health Care Providers 2
Jim Wynne The hospital: Worst place to be, especially if you're sick Hospitals, Clinics & other Health Care Providers 27
D Presenting TOP 10 diseases (Number of in-patients by diseases) in our hospital Hospitals, Clinics & other Health Care Providers 17
D Hospital benchmarking process - Rate of unplanned re-admissions Hospitals, Clinics & other Health Care Providers 5

Similar threads

Top Bottom