MDD current amendment M5 application - Questions

somashekar

Staff member
Super Moderator
#1
I have two questions and request discussion on each for clarity.
1. Article 14a - European databank
Paragraph 1 (d) : Data relating to clinical investigation as in Article 15 shall be stored in the european database.
* How to do this ?
* Will it be the domine of the EU rep for outside Europe manufacturers ?
* If I have the CE mark but never place the product in EU market, am I still obligated ?
* Must a OBL manufacturer also do this through his EU rep taking all necessary data and details from the OEM manufacturer who has the CE mark as said in the above point ?

2. ANNEX II - EC declaration of conformity (Full quality assurance system)
Paragraph 5.2
-
- the data stipulated in the part of the quality system related to design, such as the results of analysis, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post market clinical follow-up plan and the result of the post market clinical follow-up, if applicable, etc.,

How to make this <post market clinical follow-up plan and the result of the post market clinical follow-up> and must this be captured in the documented procedure for PMS ?
 
Elsmar Forum Sponsor
S

SteveK

#2
Re: Questions about MDD current amendment M5 application

I have two questions and request discussion on each for clarity.
1. Article 14a - European databank
Paragraph 1 (d) : Data relating to clinical investigation as in Article 15 shall be stored in the european database.
* How to do this ?
* Will it be the domine of the EU rep for outside Europe manufacturers ?
* If I have the CE mark but never place the product in EU market, am I still obligated ?
* Must a OBL manufacturer also do this through his EU rep taking all necessary data and details from the OEM manufacturer who has the CE mark as said in the above point ?

2. ANNEX II - EC declaration of conformity (Full quality assurance system)
Paragraph 5.2
-
- the data stipulated in the part of the quality system related to design, such as the results of analysis, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post market clinical follow-up plan and the result of the post market clinical follow-up, if applicable, etc.,

How to make this <post market clinical follow-up plan and the result of the post market clinical follow-up> and must this be captured in the documented procedure for PMS ?
Hi Somashekar,

1.My take is that it is the authority in the EU country that supplies the information. I think I had some note from the MHRA (in the UK) that they would now have to make such information available. You have to notify them, get approval and submit report etc of any clinical investigations (trials). I could be wrong on this.

2.Personally I have created a SOP for PMS (I posted this on the Cove) as part of my quality system to comply with the directive.

I hope this helps.

Steve
 

somashekar

Staff member
Super Moderator
#3
Re: Questions about MDD current amendment M5 application

Hi Somashekar,

1.My take is that it is the authority in the EU country that supplies the information. I think I had some note from the MHRA (in the UK) that they would now have to make such information available. You have to notify them, get approval and submit report etc of any clinical investigations (trials). I could be wrong on this.

2.Personally I have created a SOP for PMS (I posted this on the Cove) as part of my quality system to comply with the directive.

I hope this helps.

Steve
Hi Steve.
Thanks for that and I have made use of its contents.
However does post market clinical follow-up plan mean that we pick our own product from the field randomly and perform clinical studies and compare to the original clinical details or something like that ? Must the plan mention any periodicity for this if this is the meaning ?
With competion and tight margins this will prove costly or make the product cost go high losing out on competion.
What exactly must a manufacture do in post market clinical follow-up plan ?
 
S

SteveK

#4
Re: Questions about MDD current amendment M5 application

Hi Steve.
Thanks for that and I have made use of its contents.
However does post market clinical follow-up plan mean that we pick our own product from the field randomly and perform clinical studies and compare to the original clinical details or something like that ? Must the plan mention any periodicity for this if this is the meaning ?
With competion and tight margins this will prove costly or make the product cost go high losing out on competion.
What exactly must a manufacture do in post market clinical follow-up plan ?
Hi Somashekar,

Unless you are dealing with a Class III device I do not think clinical studies come into the equation – even then I believe you would just be monitoring for alerts, literature citations etc of yours and similar devices. My take is that ‘the plan’ is that there is an ongoing review of relevant sections of the device Technical File e.g. Clinical Evaluation, Risk Management etc. Data coming from any of the sources indicated in the PMS SOP. In my TFs this is shown by the various revisions/date changes to these sections as I gather new information and review the documents. I do not think you have to set a timeline as such – its just like painting the Forth Road Bridge; you get to the end and then start all over. This would be my ‘evidence’ of ‘the plan’ in action to the NB and/or the authorities. I don’t know if this makes any sense?

Steve
 

Peter Selvey

Staff member
Super Moderator
#5
As Steve mentioned, in many cases post market surveillance on the clinical side will simply mean a regular search for literature (i.e. clinical journals), incident reports, government notices and other published material related to your device, together with your own market feedback coming from your device (problem reports, complaints etc).

To keep NBs happy you might want to put this on an annual schedule, but it really depends on the device: for well established low risk devices longer periods might be reasonable, whereas high risk, new or problematic devices (like infusion pumps) might be shorter periods. I recommend no review period should be longer than 5 years.
 
Thread starter Similar threads Forum Replies Date
S MDD Technical File CE Mark - Addition of a Device to our Current CE Marked Family 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
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
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

Similar threads

Top Bottom