Physical Address on Product Labels (EU MDR perspective)

Ajit Basrur

Staff member
Admin
#1
I have a question regarding the mention of the physical address on the product label from an EU MDR perspective.

According to 21 CFR Part 801.1(d),
(d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of non consumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice).

My question is from an EU perspective, how is the "registered place of business" interpreted with respect to physical address on the label? Is it acceptable to delete the street address as in 21 CFR 801.1(d)?
 
Elsmar Forum Sponsor
#3
This is information provided from my Regulatory Consultant:

Yes, it is required to include the street address of both the legal manufacturer and the authorized representative, and should be the physical address, not a PO Box. Please see attached some guidance on what needs to be on the label and the instructions for use. This was developed per the requirements of section 13.3 of the Essential Requirements in the Medical Devices Directive.

If you provide an instructions for use, then the full address should be noted. The same would apply for the outer packaging labeling. I’ve pasted below some information from the attached Label guide for reference:

The function of the label is to identify who is responsible for the device and how he can be contacted. It also provides additional information for proper and safe use if this is appropriate.

Each single device should have a label and if devices are packed with more than one in larger box, that outer package should also have a label. However, if there are technical reasons a label cannot be attached to the device, the outer package is acceptable.
 
Thread starter Similar threads Forum Replies Date
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Certifcate of Free Sale Listing Physical Site from Belgium Competant Authority EU Medical Device Regulations 3
bryan willemot Chemical / physical certificate of conformance AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
N Configuration Management - Physical Audit and Functional Audit for Software and Hardware General Auditing Discussions 3
B Is a Topical Antiseptic a Physical Mode of Action? EU Medical Device Regulations 2
V Where to get Physical & Chemical Contaminants for for milk, beef, pork, mutton Food Safety - ISO 22000, HACCP (21 CFR 120) 1
S IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
O Automotive Physical Testing Methods (Norms) and Requirements Various Other Specifications, Standards, and related Requirements 1
D Medical Device Class Confimation - Device Aids in Physical Rehabilitation EU Medical Device Regulations 3
E Hardware (Such as Rivets and Bolts) - Chemical and Physical Test Reports AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
J Unbroken Chain to NIST or a Physical Property - Request for Peer Review General Measurement Device and Calibration Topics 6
D Physical Movement Deterrent for Quarantine of Goods on a Pallet-by-Pallet Basis Nonconformance and Corrective Action 8
B Property Management and Physical Security Plans Business Continuity & Resiliency Planning (BCRP) 5
C Building a Dimensional Metrology Laboratory to Inspect various Physical Measurements General Measurement Device and Calibration Topics 2
R How to select appropriate standards for Multi-Functional Physical Therapy Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Airworthiness Review - Aircraft Physical Survey EASA and JAA Aviation Standards and Requirements 1
Marc Acronym PQA - Physical Quality Assurance - Acronym Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
C Physical Configuration Audit Overview AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
D One Company divided into two but connected by a Physical Pipeline Registrars and Notified Bodies 6
quality1 Traceability by Physical Marking for Cable Assemblies Manufacturing and Related Processes 3
Q Physical vs. Digital Signature Requirements Records and Data - Quality, Legal and Other Evidence 7
D FDA Proposes Rule Reclassifying Some Neurological and Physical Medicine Devices US Food and Drug Administration (FDA) 4
D MDD 2007/ - Essential Requirement Checklist - Physical and Biological Properties EU Medical Device Regulations 4
D Recommendation for the physical design of a Cordless Phone? Other ISO and International Standards and European Regulations 1
I Glass Packaging Material (Jars) - Chemical, Physical and Biological Controls Manufacturing and Related Processes 1
Z NAVAIR PCR (Physical Configuration Review) Audit AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
M Moving from physical signatures to a paperless QMS - Process and approval sign offs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
Hershal Internal Audit - The full physical of the system General Measurement Device and Calibration Topics 7
L How to prepare preclinical physical testing? Medical device license Other Medical Device and Orthopedic Related Topics 5
V Letter of Guarantee - EN 12546-3 (Mechanical & Physical testing on an ice pack) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
S Drug product physical properties stability studies - which properties to test? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
N Auditing Inventory Levels - Computer Count vs. Physical Inventory ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
B Defining Physical Asset Maintenance KPIs (Key Performance Indicators) Benchmarking 6
K Military Program - Physical configuration Audit (PCA) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
C The Physical and Socioeconomic Impact of Lean on Resources and Pollution? Lean in Manufacturing and Service Industries 3
M DMR, DHR and DHF physical form 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Prohibited metal verification - I am not sure of a PHYSICAL way to verify this Various Other Specifications, Standards, and related Requirements 9
D Non-sector specific requirements: Do I need to write a physical procedure IATF 16949 - Automotive Quality Systems Standard 3
A Physical / Mental Capabilities and Working Conditions in Job Description? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G Survey - Physical traceability of electronic repair parts General Measurement Device and Calibration Topics 1
K Dimensional Lab (CMM Room) vs. Physical Test/Calibration Lab - Same required temp/hum General Measurement Device and Calibration Topics 2
A 6.4 Work Environment - Human and physical factors of the work environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
A How to address Environmental & OHS Opportunities? ISO 14001:2015 Specific Discussions 6
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
M Manufacturer address on the label Other US Medical Device Regulations 18
M GDPR - Is anonymizing sufficient to address right to erasure? Medical Information Technology, Medical Software and Health Informatics 3
K Implant Card - Full Manufacturer's Address - Space issues EU Medical Device Regulations 4
Similar threads


















































Top Bottom