SBS - The Best Value in QMS software

New Product Model CE Mark Certification under MDR

#1
Hi,

I would like to get some advise regarding the conformity assessment and CE certification of new product models to be added to a group of CE marked medical device family and already existing in the market.
The CE marked medical device family is a Class IIb, non active implantable device, composed of 5 product models. We are planning to add 2 or more product models, using exactly same material, the same manufacturing process but different design (a slight difference in physical dimension). Can I apply the demonstration of equivalence based on the data of medical device family already in the market, for the purpose of CE-marking certification under the MDR?.

Can you share some of your thoughts and useful references that I can follow to help me guide in applying altogether the group of medical device family, including the new product models, for CE certification under MDR?

Thank you so much for your help.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
B DPD (Digital Product Definition)/MBD (Model Based Definition) Procedure Document Control Systems, Procedures, Forms and Templates 45
T Mathematical model which represents the Gage R&R of an attribute defined product Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M REACH assessment of PCBA/finished product REACH and RoHS Conversations 0
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
Q News cradle to grave - Product life cycle ISO 14001:2015 Specific Discussions 5
J Using of CE marking - Two CE markings on the product CE Marking (Conformité Européene) / CB Scheme 5
W Final Report re: Market withdrawal of radiation-emitting product Other US Medical Device Regulations 0
M Combination Product - New MAA EU Medical Device Regulations 0
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
Z REACH compliance for low volume product REACH and RoHS Conversations 1
chris1price Notified Body responsible for product safety under MDD? EU Medical Device Regulations 4
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
A UDI for product already packed up EU Medical Device Regulations 0
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 5
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
K Interesting Discussion "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 4
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 9
P EU MDR Translation of Product Name EU Medical Device Regulations 3
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
Sidney Vianna Informational APQP4Wind - Advanced Product Quality Planning for the Wind Power Supply Chain APQP and PPAP 3
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
S How long does it take to register a product with MHRA? UK Medical Device Regulations 8
D Classification of product for clinical trials EU Medical Device Regulations 14
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
S AS9120B - 8.5.2 Delivering Split Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Classification of a product according to MDR EU Medical Device Regulations 3
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
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

Similar threads

Top Bottom