MDD, MDR/IVDR, Working Groups, Expert Panels, MEDDEVs and Other EU Guidances

Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#12
In fact, it's because they don't have a mutual recognition agreement with the EU, for conformity assessment, like Switzerland has. But also yes, it's because they can't (as the EU would not offer such as agreement).
 

Ronen E

Problem Solver
Staff member
Moderator
#15
Erik (I don't know him personally) probably has a very good grasp, and as you mention, with added political understanding, but in fact most of the information the OP mentioned is online (albeit sometime difficult to find) and open. The think is that it may take a lot of reading a lot of different document (for example, you need to read documents about how the EC product regulations/directives in general work, as the medical device ones use them as a basis and only adds our changes things) and this is what I usually see: people reads the regulation text and want answers that exists, but is not on the regulation, it's in another set of documents that form the basis of the regulations.
All the more reason to contact someone who already possesses that knowledge, and more.

I'm a great fan of DIY and digging deep, but sometimes you can save yourself a lot of time, headache and heartache by asking someone first, just to get the gist before you submerge yourself in details. Sometimes the inevitable conclusion is "stay away from that and focus on something more promising" (and I'm not trying to hint the OP that this is the case this time).
 

Watchcat

Trusted Information Resource
#17
sometimes you can save yourself a lot of time, headache and heartache by asking someone first, just to get the gist before you submerge yourself in details
Indeed, that's why I posted my query here. And not just to get the gist before submerging myself in details, but even to find out where the details could be found to submerge in! Erik responded, but he understood that I was interested in joining an MDCG, which I'm not. I'm just interested in participating in "Rev 5." If joining an MDCG were possible and that was the way to participate in Rev 5, I'd consider joining one, but really would rather not get that drawn in, even if I could.

Anyway, he expressed his doubts, with which I concur, and by then Marcelo had given me enough info for me to dig my way through to the information on the CID working group, which is probably about as far as there is to go until they get further along in the transition. So I didn't pursue it further with Erik.

I also emailed the medical devices contact at Medsafe in New Zealand, but, realistically, I'm thinking at best I might be able to submit comments during an open consultation some day, if that's how that works.
 

Watchcat

Trusted Information Resource
#19
:topic:
Just Ukraine, not "the Ukraine"
.

I have my own theory about this: People are used to adding "the" to country names that start with a U - "the US", "the UK" :)
But that doesn't explain why the British Empire crowd says "to hospital" and "to university" (in Australia, too?) while us Yanks say "to the hospital" and "to the university," nor why most people say "the FDA," while industry veterans just say "FDA." :unsure:
 

Watchcat

Trusted Information Resource
#20
I must be missing something - what's NZ got to do with it? And, are you a NZ citizen?...
Well, following Marcelo's pointer about mutual recognition agreements, I found Switzerland is one of only three countries that have MRAs with the EU for medical devices. I figure Switzerland will appoint someone on its own, since it's right there in the middle of the EU. Australia is too big, if that makes any sense. But New Zealand, maybe too small and not interested enough to appoint someone. But maybe willing to, if I'm annoying enough. ;)

No, not a citizen, but that's a rule for the expert panels. Probably also for the MDCG, but I don't want to be appointed to the MDCG, just to one of its working groups. They might not care about citizenship, or equally likely, they have stopped thinking about it by the time they got down to the level of working groups.
 
Thread starter Similar threads Forum Replies Date
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
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 1
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
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 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 23
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
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
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
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
P What ASTM std is EC 93/42 MDD EQUIVALENT TO CE Marking (Conformité Européene) / CB Scheme 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
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

Similar threads

Top Bottom