SBS - The best value in QMS software

MDD or other EU guidance that describes the need for Valid Production Processes

kreid

Involved In Discussions
#1
Hello,
Could someone point me to specific content in either the MDD or other EU guidance that describes the need for valid production processes. I am aware of the 13485 and CFR texts on this matter but I am struggling to find something specific from the MDD/MEDDEV type sources.
Thanks
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Re: Valid production processes

kreid,

Except for sterilisation*), validation of manufacturing processes is not specifically spelled out in the MDD. However, the essential requirements listed in Annex I, and especially section II, Requirements regarding design and construction, imply that you have established validated manufacturing processes.

HTH,
Gerhard

*) MDD, Annex I,
8.4 Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method.
 

RobertvanBoxtel

Involved In Discussions
#3
Look also into the requirements of Annex II (or V). On several places reference is made to control various processes. Any process shall be assessed on hazards and risks for the patient/user (ER 1-4). And validation of processes can be used as evidence of control of processes or steps thereoff. Other options are 100% QC inspection (or sampling based on AQL etc).
Look into the former GHTF documentation on process validation for terminology and methodology.

Technically, validation is only mentioned in regard to sterilization, software, and virus elimination.

But: you are not going to win this fight with your Notified Body ;)
 
Thread starter Similar threads Forum Replies Date
K PACS - interpreting MDD and Borderline Guidance CE Marking (Conformité Européene) / CB Scheme 5
P How to Produce a Technical Fle - EC Marking Guidance Needed - MDD 93/42/EEC directive ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek Upcoming NB MDD ---> MDR Crunch EU Medical Device Regulations 0
JoCam Rental and MDD versus MDR EU Medical Device Regulations 1
Ed Panek Notified Body Substantial Change MDD EU Medical Device Regulations 1
J How to keep MDD certificate valid when legal manufacturer has liquidity problem EU Medical Device Regulations 0
Ed Panek MDD Cleared Private Labelled Devices into EU EU Medical Device Regulations 0
K Section 13.6 Annex 1 MDD 93/42/EEC for Glove EU Medical Device Regulations 0
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 4
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
Q MDD - distributor EU Medical Device Regulations 1
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
M Requirements for an MDD approved device after 26/05/2021 EU Medical Device Regulations 3
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
P What ASTM std is EC 93/42 MDD EQUIVALENT TO CE Marking (Conformité Européene) / CB Scheme 1
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 14
N Label Placement Requirement in MDD/MDR EU Medical Device Regulations 1
K Measuring Function MEDDEV 2.1/5 relation with MDD 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 1
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
Z Economic Operators Responsibilities after DOA for legacy MDD devices EU Medical Device Regulations 2
J MDD to MDR transition - Time required for the implementation of the MDR EU Medical Device Regulations 7
F MDR system/procedurepack (article 22) with device acc. to MDD and MDR CE Marking (Conformité Européene) / CB Scheme 2
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
Watchcat Duration of MDD Certification EU Medical Device Regulations 4
Z MDD ER 7.5, "phthalate test"? Aspiration tips EU Medical Device Regulations 3
R Notified Body for MDD 1Q20 - Florida Company Registrars and Notified Bodies 4
S Until when can we CE-mark and sell MDD class 1 devices? CE Marking (Conformité Européene) / CB Scheme 17
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
G Harmonized List - MDD 93/42/EEC Other ISO and International Standards and European Regulations 2
B Accredited laboratory or not under MDD 93/42/EEC IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
Watchcat MDD, MDR/IVDR, Working Groups, Expert Panels, MEDDEVs and Other EU Guidances EU Medical Device Regulations 32
D MDD Certification Validity after May 2020 EU Medical Device Regulations 12
A Compatibility between MDD and MDR devices EU Medical Device Regulations 7
M Device CE certified under MDD / MDR > new GTIN? EU Medical Device Regulations 7
N When is "placing on the market"? MDD certified medical devices EU Medical Device Regulations 32
G Essential Requirements Checklist - (MDD 93/42 / EEC) Misc. Quality Assurance and Business Systems Related Topics 2
K EU MDD Class I Device market access / certification after 26th May 2020 EU Medical Device Regulations 9
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 9

Similar threads

Top Bottom