SBS - The best value in QMS software

MDD Classification of Bone Saw Handle

Dave-h

Involved In Discussions
#1
Morning all,

Just checking some clarification point for EU MDD classification.

The product in question is similar to a saw handle, to which attaches a blade which does the actual bone cutting.

The blade we're happy with as being class 2a rule 6 - non-active, surgically invasive & transient.

I am thinking that the handle to which the blade fits, would be a class 1 rule 1, (it is a manual device that is reusable) or maybe class 1 rule 6, if the handle could be described as an instrument.

Any ideas?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
renenatasha MDD Classification for Pressure Monitoring Set CE Marking (Conformité Européene) / CB Scheme 1
J0anne MDD 93/42/EEC Medical Device Classification EU Medical Device Regulations 3
E Is GHTF Classification Structure similar to EU MDD Calssification EU Medical Device Regulations 3
A Classification of ECG/EKG Electrodes according to MDD 93/42/EEC? EU Medical Device Regulations 2
somashekar Advice on Device classification under MDD Annex IX. EU Medical Device Regulations 8
F Concentrate Delivery System for Hemodialysis - MDD Classification EU Medical Device Regulations 6
W Classification of Dental Implants - MDD 2.4. Rule 8 EU Medical Device Regulations 8
L Containment Device Classification - Class I Medical Device via Rule 1 MDD Annex IX EU Medical Device Regulations 1
M MDD Classification - Marketer Has Misclassified A Product? EU Medical Device Regulations 22
M Harmonization of device classification with EU MDD? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N MDD Classification of Software which Supports Physicians - Premie Nutrician ISO 13485:2016 - Medical Device Quality Management Systems 6
T European MDD Classification of Medical Devices (Risk Class) EU Medical Device Regulations 15
J Nuclear Medicine Dose Calibrator Classification (MDD) 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
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

Similar threads

Top Bottom