MDD x PPE Directive - Statement of Non-Applicability

Regulatory

Starting to get Involved
#1
Hello Everyone,
We manufacture X-Ray medical diagnostic equipment .Per MDD 93/42/EEC our device fall in Class IIb but we got an observation from our auditor that we have to provide any documentation/ evidence relating to applicability/non-applicability of the Personal Protective Equipment Directive 89/686/EEC (and/or the current regulation 2016/425) per MDD Article 1(6)?
PPE directive is applicable for us or not please suggest and which document or evidence we can provide to fulfill the above said requirement.
Any help or advice would be great.
 
Elsmar Forum Sponsor

Regulatory

Starting to get Involved
#2
Hello Everyone,
We manufacture X-Ray medical diagnostic equipment .Per MDD 93/42/EEC our device fall in Class IIb but we got an observation from our auditor that we have to provide any documentation/ evidence relating to applicability/non-applicability of the Personal Protective Equipment Directive 89/686/EEC (and/or the current regulation 2016/425) per MDD Article 1(6)?
PPE directive is applicable for us or not please suggest and which document or evidence we can provide to fulfill the above said requirement.
Any help or advice would be great.
would be thankful if anyone share their views...
 

chris1price

Trusted Information Resource
#3
Because of the overlap of the two MDD and PPE directives, there is a need to state in your technical files, that the PPE Directive is not applicable to your medical device. I suspect this is what your NB is looking for. As long as it is obviously true, one sentence should be sufficient.
 
Thread starter Similar threads Forum Replies Date
GStough Looking for someone with experience in MDD, PPE, CMDR/CMDCAS regs General Auditing Discussions 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 3
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
Q MDD - distributor EU Medical Device Regulations 1
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
shimonv Checklist for MDD to MDR gap analysis EU Medical Device Regulations 18
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
I MDD Class I software technical documentation sample 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

Similar threads

Top Bottom