What MDD (Medical Device Directive) Annex to follow for Class I device?

B

Bunny

#1
We are a Class I medical device manufacturer. What is the correct Annex that should be followed?
 
Elsmar Forum Sponsor

bio_subbu

Super Moderator
#2
Re: What MDD Annex to follow for Class I device?

We are a Class I medical device manufacturer. What is the correct Annex that should be followed?
Please provide some more information about your product such like intended use, if the device is sterile or have a measuring function and so on..
 
M

MIREGMGR

#4
Your intended conformance path (i.e. which MDD Annex you will utilize as the basis for your device compliance) must have been discussed and decided with your Notified Body during their initial interactions with you preparatory to your getting your CE certificate. I'd expect that conformance path to be stated on the CE certificate.
 

bio_subbu

Super Moderator
#5

Attachments

M

MIREGMGR

#8
Assuming you have a CE certificate, it would be a bad idea to devote work toward a conformity path other than what is pre-defined in that regard.
 
J

Johnny_Bravo

#9
What CE certificate if this is a class I non-measuring non-sterile? How could they get the CE certificate if they didn't know which conformity assement route (Anex) to follow?

As FilipeF said, answer is simply Anex VII without question.
 
Thread starter Similar threads Forum Replies Date
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
F MDD Article 12 Labeling Requirements for CE Marked Medical Device - Help CE Marking (Conformité Européene) / CB Scheme 4
S Final Medical Device Regulations replacing MDD 93/42/EEC, etc. EU Medical Device Regulations 15
N MDD Class I Medical Device Self Declaration Articles/Supplementary Documents EU Medical Device Regulations 1
R Class I Medical Device will be Class IIa after new MDD EU Medical Device Regulations 3
rob73 New MDD (European Medical Device Regulations) next steps - 2016 EU Medical Device Regulations 1
J0anne MDD 93/42/EEC Medical Device Classification EU Medical Device Regulations 3
M Do I need to comply with both the MDD and the PED for my Medical Device? EU Medical Device Regulations 8
P EU MDD revisions white paper on the proposals for the Medical Device Regulations EU Medical Device Regulations 1
A MDD 93/42 EEC - Requirements for Detachable Medical Device Components EU Medical Device Regulations 4
S MDD 93/42 Annex I 12.3 - Medical Device Electrical Alarm Requirements EU Medical Device Regulations 3
B Bangladesh Class IIA Medical Device MDD Registration Requirements Other Medical Device Regulations World-Wide 6
C Mobile Medical Device for MDD - Medical Image Viewer EU Medical Device Regulations 2
M Proposed EU MDD (Medical Device Directive) Revision(s) - 2012 - 2013 EU Medical Device Regulations 16
Q Storage Temperature - Medical Device - Objective Evidence - MDD 93/42/EEC Other Medical Device Regulations World-Wide 1
B Certificate of Exportability of Class IIA (EU MDD) Medical Device US Food and Drug Administration (FDA) 1
D MDD (Medical Device Directive) 6.1 Record Retention Requirements question Records and Data - Quality, Legal and Other Evidence 2
L MDD (Medical Device Directive) Compliance Review checklist wanted EU Medical Device Regulations 9
G IVD (In Vitro Diagnostic) MDD (Medical Device Directive) Borderline Issues EU Medical Device Regulations 3
T MDD (Medical Device Directive) and ISO 13485 and a lot of Questions EU Medical Device Regulations 3
P Do MDD (Medical Device Directives) Devices require MDD components? EU Medical Device Regulations 17
M MDD (Medical Device Directive) Online Training Recommendations and Suggestions EU Medical Device Regulations 1
xcanals_tecno-med.es Revised List of Harmonized Standards for Medical Device Directives (MDD) in the EU EU Medical Device Regulations 48
R Declaration of Conformity - MDD (Medical Device Directive) 2007/47/EC or 93/42/ECC CE Marking (Conformité Européene) / CB Scheme 9
ScottK MDD (Medical Device Directive) and Secondary Packaging EU Medical Device Regulations 3
E Does MDD (Medical Device Directive) Require a CAPA Procedure? Document Control Systems, Procedures, Forms and Templates 3
D Requirement of "State Of The Art" in MDD (Medical Device Directive) EU Medical Device Regulations 42
P Medical Device Vigilance - MDR or MDD? EU Medical Device Regulations 9
E MDD 2007/47/EEC - Medical Device Directive Labeling Changes EU Medical Device Regulations 44
J Medical Device Directive (MDD) 2007/47/EC and 2006/42/EC EHSR checklist EU Medical Device Regulations 7
L Containment Device Classification - Class I Medical Device via Rule 1 MDD Annex IX EU Medical Device Regulations 1
L MDD Definition of Address as it applies to Medical Device Labeling EU Medical Device Regulations 20
S Standards used for Medical Device MDD Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 25
W MDD (Medical Device Directive) Essential Requirements Checklist ISO 13485:2016 - Medical Device Quality Management Systems 18
echo7tango MDD (Medical Device Directive) Update? The copy I have is 14 June 1993 (93/42/EEC) Other ISO and International Standards and European Regulations 13
S MDD (European Medical Device Directive) requires subset of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
W New List of Medical Device Harmonized Standards - MDD CE Marking (Conformité Européene) / CB Scheme 5
chris1price The status of the 2005 ammendments to the MDD (Medical Device Directive)? EU Medical Device Regulations 4
T Calculating Basic Risk/ Basic on Risk Analysis - Medical device MDD Class II and up ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Medical Device Directive - Anyone know of any good MDD training courses Training - Internal, External, Online and Distance Learning 11
V CE Marking for Power Supply for Medical Device - Class IIb device per MDD, Rule 11 EU Medical Device Regulations 3
H Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC) ISO 13485:2016 - Medical Device Quality Management Systems 3
C Medical Device QMS manual - MDD, AIMD, 21 CFR part 820, CMDCS, and the new ISO 13485 Quality Management System (QMS) Manuals 3
D Getting Started - ISO13485:2003 and MDD (Medical Device Directive) ISO 13485:2016 - Medical Device Quality Management Systems 9
N When is "placing on the market"? MDD certified medical devices EU Medical Device Regulations 32
R Identification of Medical Devices in MDD 93/42 Certificate EU Medical Device Regulations 2

Similar threads

Top Bottom