SBS - The Best Value in QMS software

Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date?

#1
Hi Elsmar Community!

I am in the process of EU MDR compliance for Class I devices and there is a question on label updates per EU MDR Annex I Chapter 3. Per the new requirement we need an indication that the device is a medical device and we have chosen to go with the industry standard label symbol "MD". However, what I need help understanding is whether this label needs to be applied to all CE-marked (Class I) devices that have already been built and are currently in the inventory. To provide more details, these products are final finished devices (non-sterile) that have been packaged and labeled already. Will these require re-labeling?
 
Elsmar Forum Sponsor
#2
Hi Prkpr,

The EU MDD/ EU MDR compliance switch applies depending on when devices are "first placed on the market," as defined in the EU MDR and as further elaborated in the Blue Guide. It is very possible that your packaged and labeled devices could have already been placed on the market in the EU, so long as 1) they have been imported to the EU; or 2) they have been manufactured in the EU, and have moved far enough along the supply chain that they could theoretically be sold out of their inventory location. If the devices have been placed on the market in this way, you should not be required to re-label.

One word to the wise, the "MD" symbol in the ISO 15223-1:2020 version of the standard has 1) not yet been formally released by standardization body ISO ( :2020 standard version is still in development), and 2) nor has it been harmonized to EU MDR, so it's worth considering whether/how you'll fulfill translation requirements into national languages for this GSPR, since the symbol doesn't take care of that by default absent its harmonization. If you've already got a plan for how to address that, I'd be curious to hear the solution that you've come up with!
 
#3
Thank you for the detailed response, mboynton. In the case at hand, we do not currently sell in Europe but maintain a CE Mark on the devices for business reasons. Therefore, the inventory I am referring to is not yet in the EU. Based on your comment, "The EU MDD/ EU MDR compliance switch applies depending on when devices are "first placed on the market,"", it looks like we will have to re-label any CE Marked devices in inventory (not in EU but in US) with an indication that it is a medical device - is this correct?

Also - I am curious what the purpose is of the indication that the device is a medical device - is it for customs? is it for physicians? is it for patients? This answer in my mind will answer my next question: Does the indication/symbol need to exist at all levels of packaging from the higher level package to the device primary package?

Thoughts, ideas, suggestions, concerns - all welcome!
 
Thread starter Similar threads Forum Replies Date
M Do employee training records need to be controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D What evidence to I need to supply as a remote location in relation to manufacturing sites? IATF 16949 - Automotive Quality Systems Standard 10
T Non API products need to comply to API Q1? Oil and Gas Industry Standards and Regulations 3
G Need journal and reference of abnormal bar chart SPC Statistical Analysis Tools, Techniques and SPC 3
MSeibert47 Daily Quality Topics - Need Ideas Please! Food Safety - ISO 22000, HACCP (21 CFR 120) 15
W Do Reference materials for IATF need to be 17025? IATF 16949 - Automotive Quality Systems Standard 15
D Need some Help on 8D fault tree analysis Problem Solving, Root Cause Fault and Failure Analysis 6
A Need to calculate tolerance Intervals with a set of non-normal data and 3-Parameter Weibull distribution Using Minitab Software 0
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 10
F Need Quality Manager advice. Quality Manager and Management Related Issues 6
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Do CTQs need to be equipment specific? FMEA and Control Plans 8
K Contract Manufacturer Do they need a complaint procedure? Medical Device and FDA Regulations and Standards News 8
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
D Do employee training records need to be centralized? IATF 16949 - Automotive Quality Systems Standard 10
H Need of EU Representative Designation for Turkey? EU Medical Device Regulations 3
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
briteme4 AS9102 First Article Inspection - do I need a second reviewer and signer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Furnace repaired - Do I need a new initial TUS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
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
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 6
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K Interesting Discussion "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
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
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
K Do I need a "State of the art" plan? CE Marking (Conformité Européene) / CB Scheme 1
S Need advice for schooling Quality Manager and Management Related Issues 5
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
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
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4

Similar threads

Top Bottom