MDD Classification for Pressure Monitoring Set

renenatasha

Involved In Discussions
#1
Good day, Clover :)

I tried searching the thread but can't find anything that comes close to my doubt.

In regards to classifying a pressure monitoring set (consists of a range of consumables and single use components), is it possible to classify the whole device lower (based on the intended use of the final device) as Class IIa? The kit, however, contains a Class IIb component which is the pressure transducer.

Any advice please?

Thanks in advance :)
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
Article 12 applies for systems and procedure packs.

If all of the items in your set are independently CE marked then you can write a declaration that all components are compatible. If you sterilise the components you need to involve a notified body to review the sterility aspects. The set is not in it's own classified as I IIa,b or III; it relies on the original CE marks.

It becomes a bit more complex if one or more of the components are not CE marked in their own right;
 
Thread starter Similar threads Forum Replies Date
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
D MDD Classification of Bone Saw Handle ISO 13485:2016 - Medical Device Quality Management Systems 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
Jerome Nuclear Medicine Dose Calibrator Classification (MDD) ISO 13485:2016 - Medical Device Quality Management Systems 5
S Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 3
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
Kuldeep Singh 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
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

Similar threads

Top Bottom