MDD to MDR - Tallow Derivatives Impact

#1
Hi,
Hoping to get some advice here - we have a range of class IIA plastic medical devices which are non-surgically invasive.
We have just received confirmation that one of our component suppliers uses tallow as a mold release agent during manufacturing of the component.
According to MDD Rule 17, following MEDDEV 2_4_1_rev_9_classification_en, we do not have to classify our device as Class III as tallow used in the manufacturing is not considered a derivative of animal tissue, see wording from MEDDEV below;
"The manufacture of some devices may use industrial raw materials which contain small amounts of tallow or tallow derivatives (e.g. stearates in polymers). Such substances are not considered as derivatives of animal tissues for the purpose of this rule which therefore does not apply."

However under MDR, Rule 18, there are no classification guidelines and I cannot locate any document that discusses whether tallow derivative is considered to be an animal tissue derivative under MDR, rule 18.

Does this mean that under MDR, our devices which use tallow derivatives as a mold release agent would be considered to be a Class III, rule 18 device?
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
In the absence of a more specific MDR definition, you might want to built an argument to continue following the above quoted MEDDEV guidance and continue classifying your device(s) as IIA. You might want to re-confirm this rationale / classification decision with your notified body.
 
Thread starter Similar threads Forum Replies Date
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
H MDD VS MDR 2002-218 UK Medical Device Regulations 6
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
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 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
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
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 3
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
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
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
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
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 9
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
shimonv Checklist for MDD to MDR gap analysis EU Medical Device Regulations 23
M Informational Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) Medical Device and FDA Regulations and Standards News 5
S EU conformity assessment - Certify to MDD or MDR? EU Medical Device Regulations 3
Rincewind Pressure energy - Essential Requirements (MDD/MDR) EU Medical Device Regulations 2
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
V How do I get a rough MDD to MDR gap analysis by clauses Other Medical Device Related Standards 5
B MDD or MDR Definition of metabolic EU Medical Device Regulations 2
chris1price Is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock recall? CE Marking (Conformité Européene) / CB Scheme 4
Sam Lazzara EU MDR Safety & Performance Requirements vs. MDD ERs (June 2017) EU Medical Device Regulations 3
S Comparison of US MDR and EU MDD EU Medical Device Regulations 6
P Medical Device Vigilance - MDR or MDD? EU Medical Device Regulations 9
L Significant subcontractor update, still under MDD Certification, possible? CE Marking (Conformité Européene) / CB Scheme 3
marmotte MDD legacy until 2024 - EUDAMED, role (and cost!) of the EC Rep EU Medical Device Regulations 4
W MDD Distributor Registration Requirements Other Medical Device Regulations World-Wide 0
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 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
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

Similar threads

Top Bottom