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
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 7
L Class I under MDD EU Medical Device Regulations 1
O MDD products under MDR certificate EU Medical Device Regulations 12
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
K MDD to MDR Other Medical Device and Orthopedic Related Topics 4
K Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body? CE Marking (Conformité Européene) / CB Scheme 8
K Selling legacy device under MDD to India EU Medical Device Regulations 1
G Updating MDD devices after MDR transitional period EU Medical Device Regulations 0
P Servicing of Class IIb devices under MDD EU Medical Device Regulations 2
G Significant changes on MDD devices/Old Devices after MDR transitional period EU Medical Device Regulations 1
S Changing PCB Assembler and impact on QMS and MDD CE Certificate EU Medical Device Regulations 2
Ed Panek Auditor Comment about MDR vs MDD EU Medical Device Regulations 10
O MDD 93/42 and making documentation available EU Medical Device Regulations 1
M Reworking MDD product w MDR labeling CE Marking (Conformité Européene) / CB Scheme 5
A Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device EU Medical Device Regulations 1
L Significant subcontractor update, still under MDD Certification, possible? CE Marking (Conformité Européene) / CB Scheme 3
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
marmotte MDD legacy until 2024 - EUDAMED, role (and cost!) of the EC Rep EU Medical Device Regulations 6
H MDD VS MDR 2002-218 UK Medical Device Regulations 6
W MDD Distributor Registration Requirements Other Medical Device Regulations World-Wide 0
S MDD to MDR - Tallow Derivatives Impact EU Medical Device Regulations 1
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 6
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
chris1price Notified Body responsible for product safety under MDD? EU Medical Device Regulations 4
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 5
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 4

Similar threads

Top Bottom