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New MDD (European Medical Device Regulations) next steps - 2016

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S MDD (European Medical Device Directive) requires subset of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
T European MDD Classification of Medical Devices (Risk Class) EU Medical Device Regulations 15
A European Notified Body (MDD 93/42/EEC) Survey - Analysis will be posted. ISO 13485:2016 - Medical Device Quality Management Systems 12
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 1
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 8
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 4
F Class I Device under MDD, reclassified to Class II under MDR Other Medical Device Related Standards 5
S Dual MDD and MDR certification EU Medical Device Regulations 7
K Obligation for Distributor in MDD/MDR CE Marking (Conformité Européene) / CB Scheme 4
D MDD to MDR - Technical File conversion EU Medical Device Regulations 4

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