Product Service after CE Certification expiration

#1
Due to low EU sales volumes, our company is considering discontinuing EU product sales after expiration of our current CE certificate.

The product is Class IIa with CE scope certification noted as “Design and Manufacturing”.

We will continue to maintain a QMS that is ISO 13485:2016 compliant and perform all associated activities (complaint handling, medical device reporting/recall, PMS) for the product.

Once the CE certificate has expired, can the company continue to perform service/repair activities for our EU customers on existing/previously sold product?

Thanks in advance,

JG
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
I could argue both ways, it's a grey area question.
If you can, I think that your best bet would be to ask your NB.
As far as I can tell the MDD is not specifically concerned with maintenance / servicing / repair, other than in the PMS aspect. There might be other EU directives / regulations that apply though.
 
Thread starter Similar threads Forum Replies Date
W ISO 9001 certification (registration) requirements - No commercial product or service ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 42
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Nonconforming product at customer detected by a routine inspection by field service Nonconformance and Corrective Action 9
M Informational New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen Medical Device and FDA Regulations and Standards News 1
S Product registration platforms - A service called Licensale by Arazy Group Medical Information Technology, Medical Software and Health Informatics 0
W Product or Service? Custom Engineered Capital Equipment Manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A ISO 13485 - Controlling Production and Service Provision - Product Catalogues ISO 13485:2016 - Medical Device Quality Management Systems 3
J Service Industry Quality Manual and Product Realization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Scope of TS16949 for Aftermarket Product and a Service Fill Product IATF 16949 - Automotive Quality Systems Standard 2
I Interpreting Product Realization (Clause 7) in ISO 9001:2008 for Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Product=Service in ISO 9001 and ISO 9001 Requirements vs. TS16949 Requirements IATF 16949 - Automotive Quality Systems Standard 2
I Hospital Product/Service Realization and Monitoring/Measurement (ISO 9001) Hospitals, Clinics & other Health Care Providers 4
N Product Validation Worksheet for the Electronic Manufacturing & Service Industry Human Factors and Ergonomics in Engineering 1
GStough 7.2.1 Determination of req'ts related to the Product...in Contract/Service Industry Service Industry Specific Topics 2
Z If this is a Nonconforming Product (Service) under clause 8.3? How do we handle it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M 7.2.2 Review of Requirements Related to the Product (Design-Manufacturing Service) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
W QC Audits and Product Audits in a Service Provider Internal Auditing 3
G Why is Service Quality different than Product Quality? Quality Tools, Improvement and Analysis 11
I Integrated Management System - Nonconforming Service/Product Defects ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Cleanliness of Product & Service and Contamination Control ISO 13485:2016 - Medical Device Quality Management Systems 6
M Quality and Reference - Recommending a product or service or company or brand Philosophy, Gurus, Innovation and Evolution 5
Z 7.1d Product Realization Records in a Small Cleaning and Painting Service Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Control of Nonconforming Product in a Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Confused with 7.4 Purchasing - We provide a "service" which is our "product" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Monitoring & Measurement of Product for Service Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Applicability of 7.5.5 Preservation of Product in a Service Industry like Insurance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
I Non-conforming product procedure - For a Service Company Document Control Systems, Procedures, Forms and Templates 8
A Preservation of Product - Service Industry - AS9100 Clause 7.5.5 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
A Service base Non-conforming Product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Non-Conformances in a Service based industry with no product Service Industry Specific Topics 9
G Looking for ideas "How to word" Warranty or Product Service into manual Quality Management System (QMS) Manuals 3
S First Article Inspection in an AS9100 service industry (Final product non tangable) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
T Product / Service Life Cycle Quality - Whose Responsibility to Sort, etc.? Philosophy, Gurus, Innovation and Evolution 1
S APQP - Definitions of service and product quality characteristics APQP and PPAP 1
K Is "service" a product in terms of ISO TS 16949? Service Industry Specific Topics 14
A 7.5.1.2.1 Cleanliness of Product and Contamination Control - Service Provider Service Industry Specific Topics 2
D Confused over product=service=transport Service Industry Specific Topics 2
J Design exclusion - Service company that processes only customer supplied product Design and Development of Products and Processes 2
H What is a Service vs. What is a Product? Production and Service provision Service Industry Specific Topics 16
Marc Design - Widget vs. Service Organization Product Design and Development of Products and Processes 16
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2

Similar threads

Top Bottom