List of Medical Device Accredited Warehouses in the EU

J

Jordan Peters

#1
I am looking for a list of warehouses in the EU that can handle pick and pack operations for medical devices.

What is the licensing body that accredits warehouses for medical device handling? Do they just need ISO 13485 or are there other licenses they would require?

Where would I get a list of all of these warehouses in the EU?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Medical Device Accredited Warehouse in the EU

Hello and welcome to the cove :bigwave:

I am looking for a list of warehouses in the EU that can handle pick and pack operations for medical devices.
I assume that you refer to warehouses providing logistic services -- namely, receiving packaged and labeled goods, storage and re-distribution (secondary packaging and shipment) -- without being involved in the primary packaging and labeling of the medical devices. Is that correct? In that sense any well-organised warehouse that applies Good Distribution Practices would do, though knowledge of and sensitivity to the unique characteristics of medical devices supply in general, and the specific ones that relate to the type of devices at stake (e.g. is it temperature sensitive? does it have limited shelf life? etc.) would be a bonus of course.

What is the licensing body that accredits warehouses for medical device handling?
I'm not aware of the existence of such dedicated body. I tend to think the relevant bodies would be ISO 9xxx registrars.

Do they just need ISO 13485 or are there other licenses they would require?
If they don't pack and/or label medical devices (primary packaging and labeling) then I reckon they don't need ISO 13485 or any other medical devices related "license". I would, however, expect them to implement all relevant medical device storage, distribution and post-marketing activities that are mentioned in the MDD and ISO 13485. That would apply through your contract with them, not directly as a regulatory burden that they must bear.

Where would I get a list of all of these warehouses in the EU?
Sorry, I don't know of such list, but if I needed one I'd first try the official EC sites for clues. Hopefully other covers will come up with more.

Cheers,
Ronen.
 

pkost

Trusted Information Resource
#3
As Ronen has already said, there is no need to hold a license to distribute medical devices in the EU. All of the regulatory responsibility lies with the manufacturer.

There is no need or requirement for 13485 either - or 9001 - unless required by the manufacturer!
 
M

mikeashby

#4
Good to know that this forum exist. I been searching for long hours now regarding this matter. Thanks!
 
M

mikeashby

#5
All storage of warehouses have different categories per item stored. You can ask the storage salt lake city for further matters regarding your concerns.
 
Thread starter Similar threads Forum Replies Date
T Medical device Clinical trial exemption list China Medical Device Regulations 2
A Docs for Medical Device registration in China - List of certificates China Medical Device Regulations 6
Y How to List a Medical Device Other US Medical Device Regulations 2
L Employee Signature List for Medical Device Company ISO 13485:2016 - Medical Device Quality Management Systems 8
xcanals_tecno-med.es Revised List of Harmonized Standards for Medical Device Directives (MDD) in the EU EU Medical Device Regulations 48
P Essential List of SOPS for a Medical Device Development & Submission Process? ISO 13485:2016 - Medical Device Quality Management Systems 4
xcanals_tecno-med.es Revised list of harmonized standards for medical device directives in the EU (7/7/10) EU Medical Device Regulations 0
M IEC 60601 - List of required tests - Medical Device Class IB IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
R Medical Device: New List of Harmonized Standards in EU under MDD93/42/EEC EU Medical Device Regulations 6
M Revised list of harmonized standards for medical device directives in the EU EU Medical Device Regulations 1
K List of Recognized product certification by country for Medical Device Various Other Specifications, Standards, and related Requirements 4
Q JMDN (Japanese Medical Device Nomenclature) codes list needed Japan Medical Device Regulations 23
T PMA (PreMarket Approval) Check List example wanted for Class III Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V List of Global Medical Device Nomenclature (GMDN) Codes Other Medical Device and Orthopedic Related Topics 48
W New List of Medical Device Harmonized Standards - MDD CE Marking (Conformité Européene) / CB Scheme 5
M Medical Device DMR's - List of the Marketing or Market Penetration documents ISO 13485:2016 - Medical Device Quality Management Systems 14
H Approval list for mechanical and electronics drawings in a Medical Device company ISO 13485:2016 - Medical Device Quality Management Systems 3
D Approved Vendor (Supplier) List Issues - Class II medical device maker Supplier Quality Assurance and other Supplier Issues 2
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
H IS there any database for list of CE marked Medical devices and there current status EU Medical Device Regulations 8
L List of Regulated Countries - Registrations on Medical Devices Class I / II / III Other Medical Device Regulations World-Wide 2
M List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 3
A CFDA - List of Class II Medical Devices exempt from Clinical Trials China Medical Device Regulations 2
bio_subbu India's CDSCO issues a list of Medical Devices that require Registration Other Medical Device Regulations World-Wide 8
A List of FDA recognized standards for medical devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Is there an Approved Pigment List to be used in Medical Devices ? US Food and Drug Administration (FDA) 8
P List of Standards for different Electrical/Medical Parts or any Test Procedures Other Medical Device Related Standards 4
A US FDA Approved Materials (which can be used for Medical Devices) List? Other US Medical Device Regulations 3
T List of Medical Devices - Registered in Republic of Indonesia Other Medical Device Regulations World-Wide 1
W No-No List of raw materials in medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 4
L Internal Audit Check List for Passive Medical Equipment ISO 13485:2016 - Medical Device Quality Management Systems 5
A List of Countries Using ISO standards (medical devices in particular) ISO 13485:2016 - Medical Device Quality Management Systems 5
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
bryan willemot Looking for an Approved vendors list template Document Control Systems, Procedures, Forms and Templates 11
U Approved Vendor (supplier) List Supplier Quality Assurance and other Supplier Issues 8
M Management review check-list Management Review Meetings and related Processes 3
lanley liao How to correctly understand the bullet list d) of 6.3 Analysis of Data for API Spec Q1 Oil and Gas Industry Standards and Regulations 7
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
lanley liao How to understand this bulleted list from API 600 Oil and Gas Industry Standards and Regulations 0
D Approved supplier list for R&D ISO 13485:2016 - Medical Device Quality Management Systems 5
R Qualification list of businesses approved to Off-Shore Aerospace work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
F List of countries that 'prefer' a CE Mark CE Marking (Conformité Européene) / CB Scheme 1
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
G MSA check list to audit IATF 16949 - Automotive Quality Systems Standard 10
D List A IVD - Change to material supplier EU Medical Device Regulations 3
M Sites to List on Multi-Site Certifications Registrars and Notified Bodies 1
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
G Assignable cause/corrective action list for SPC Software Statistical Analysis Tools, Techniques and SPC 3

Similar threads

Top Bottom