Self Declaration for CE Class I, Non-Invasive Medical Device

T

topher4209

#1
#1
Forum,

First off let me say that this cove is awesome and helpful.
Now if I have classified my 3 product families correctly and they are Class I, rule 1 (non-invasive, without a measuring device) I can self declare my product. I have also built my Technical Files. What is the next step to self declare?

I have a lot of experience with the FDA CFR, but not CE so any help you be great.

:thanx:
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Moderator
#2
#2
topher4209 said:
Forum,

First off let me say that this cove is awesome and helpful.
Now if I have classified my 3 product families correctly and they are Class I, rule 1 (non-invasive, without a measuring device) I can self declare my product. I have also built my Technical Files. What is the next step to self declare?

I have a lot of experience with the FDA CFR, but not CE so any help you be great.

:thanx:
Click to expand...
Hi,

The MDD is your best friend. I recommend reading it cover to cover, excluding annexes II-VI (inclusive). For class I self-declaration follow annex VII.

Cheers,
Ronen.
 
T

topher4209

#3
#3
Thank you. Everything I search is pretty vague. But it gives me a direction.
 
Last edited by a moderator:
S

sreenu927

Quite Involved in Discussions
#4
#4
In short, as you already compiled a technical file, now draw an EC Declaration of Conformity as per the format. Release your Technical file per your document control process. From the released date/EC DoC signed date, you can manufacture your products and paste the label bearing CE Marking and the ECREP contact address, and start shipping to EU.
If you want to ship to non-English speaking EU countries, then you must translate your labelling into that corresponding language, before you ship to that country.

Regards,
Sreenu
 
T

topher4209

#5
#5
The country is Denmark. I thank you for the information. I love this site. I have been doing this for 12 years but CE is a mystery to me.
 
T

topher4209

#6
#6
European Authorised Representative Medical Devices

Again I love this site. I need an AR to call me back so I can class my product and move forward. As I stated on a deadline, and we are a small organization. I have contacted many AR's I need feedback please. :bigwave:

Warm Regards,

Christopher, CQE
 
Ronen E

Ronen E

Problem Solver
Moderator
#7
#7
Re: European Authorised Representative Medical Devices

topher4209 said:
Again I love this site. I need an AR to call me back so I can class my product and move forward. As I stated on a deadline, and we are a small organization. I have contacted many AR's I need feedback please. :bigwave:

Warm Regards,

Christopher, CQE
Click to expand...
Hi,

You don't need an AR "to class your product". You classify your own product. You need the AR to register your class I with a Competent Authority. You also need an AR because the MDD requires that you have one if you don't have a place of business registered in a Member State. It's all in the MDD which is available to all, online, free of charge.

What feedback are you looking for?

Cheers,
Ronen.
 
T

topher4209

#8
#8
Re: European Authorised Representative Medical Devices

I thought I needed an AR to class in case my classification was incorrect. As I said I'm new to CE I have read everything this site as provided. I was under the impression that an AR still audits or overviews at least one of my 3 Technical files.

Thank you for the information.
 
Q

QualityGuy50

#9
#9
sreenu927 said:
In short, as you already compiled a technical file, now draw an EC Declaration of Conformity as per the format. Release your Technical file per your document control process. From the released date/EC DoC signed date, you can manufacture your products and paste the label bearing CE Marking and the ECREP contact address, and start shipping to EU.
If you want to ship to non-English speaking EU countries, then you must translate your labelling into that corresponding language, before you ship to that country.

Regards,
Sreenu
Click to expand...
I'd agree with this but add that registration with the Competent Authority of the country where the legal manufacturer is based is needed before affixing the CE mark and selling. There may be a small fee (a few hundred euro) for registration and periodic renewals depending on the Competent Authority.

The conformity assessment route followed will be Annex VII (self-declaration and registration with Competent Authority) provided the device is not provided sterile and does not have a measuring function.
 
Ronen E

Ronen E

Problem Solver
Moderator
#10
#10
Re: European Authorised Representative Medical Devices

topher4209 said:
I thought I needed an AR to class in case my classification was incorrect. As I said I'm new to CE I have read everything this site as provided. I was under the impression that an AR still audits or overviews at least one of my 3 Technical files.

Thank you for the information.
Click to expand...
Hi,

As above, everything basic that you need to know is in the MDD. It includes what the AR role is (and isn't). The AR is not supposed to audit or challenge your classification. In fact, they're not required to master classification or any other regulatory aspect except registration of class I devices and their post-marketing surveillance / vigilance obligations. Some ARs would have broad knowledge and would be able to consult, but this is not required by the MDD and is not what they're there for, in regulation terms. Your conduct regarding non-sterile non-measuring class I devices is mostly up to you. In higher classes the oversight lies with the NB.

It's good to read threads in Elsmar but IMO this should be in addition to the MDD, not instead.

Cheers,
Ronen.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
N MDD Class I Medical Device Self Declaration Articles/Supplementary Documents EU Medical Device Regulations 1
C Class I Medical Device - What is in a CE Marking Self-Declaration EU Medical Device Regulations 18
MichaelDRoach Oganization's Self Declaration of Conformance to ISO 28000 wording example wanted Supply Chain Security Management Systems 1
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 12
A R2 Certification vs Self Declaration to ISO 14001 and OHSAS 18001 ISO 14001:2015 Specific Discussions 3
P ISO/TS 16949:2009 Compliance - Self Declaration Audit IATF 16949 - Automotive Quality Systems Standard 4
rob73 Length of validity of a self certified Declaration of Conformity (DoC) for CE mark EU Medical Device Regulations 4
N Is RoHS issued only by self declaration process? RoHS, REACH, ELV, IMDS and Restricted Substances 3
T CE Mark or Self Declaration for Plano Lens CE Marking (Conformité Européene) / CB Scheme 6
W CE Marking for Baby Crib Mattress - Which Directive? Is self declaration enough? CE Marking (Conformité Européene) / CB Scheme 15
B Self assessment / Self declaration of ISO 14001 ISO 14001:2015 Specific Discussions 14
Q Self Declaration or Registration to ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L ISO 14001 Self Declaration - I'm guessing most companies don't go this route ISO 14001:2015 Specific Discussions 8
Z COVID-19 Antigen Test Kit (Self-test) Registration in Peru Other Medical Device Regulations World-Wide 0
F Self Evident Inspection Method ISO 13485:2016 - Medical Device Quality Management Systems 11
F Self-test minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
F Medical cart self certification EU Medical Device Regulations 1
M IATF 16949 SI # 10: Integrated self-calibration of measurement equipment- Needs for explanation IATF 16949 - Automotive Quality Systems Standard 2
A Self-training or Self-studying ISO 13485:2016 - Medical Device Quality Management Systems 8
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Control-self assessment Internal Auditing 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
E HONDA HAA QAV-1 Self Assessment General Auditing Discussions 4
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
G Self Assessment Audit from a new potential customer General Auditing Discussions 3
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
K Intended Use-Class I Self Certified - Intended Use and Indications for Use statements EU Medical Device Regulations 1
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
M Medical Device News TGA – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018 Medical Device and FDA Regulations and Standards News 0
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
M CE self-certify, or needs testing by 3rd party? CE Marking (Conformité Européene) / CB Scheme 12
M Notified Body Involvement with Self Declared Products EU Medical Device Regulations 7
S Help: Need Control Self Assessment Questionnaire for HR Departmental Functions Process Audits and Layered Process Audits 0
R Documenting Self-Training and Effectiveness - ISO 13485:2016 Training - Internal, External, Online and Distance Learning 4
K ISO 13485:2016 Self Certification for Class I (annex 9) Stand-Alone Software? ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO9001:2015 and ISO14001:2015 Readiness/Self Evaluation Checklists wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Self-study plan to improve fluency in English speaking, writing After Work and Weekend Discussion Topics 3
Crusader Interval for Self-Calibrating Measurement Device? Calibration Frequency (Interval) 15
T Transition Time for Self Declared IVDs EU Medical Device Regulations 3
Z IVD Self Test Pregnancy - Assessment Route? EU Medical Device Regulations 5
S Anyone know the self-selection study for home use medical device Other US Medical Device Regulations 2
D Off-Label Self Promotion - What to do EU Medical Device Regulations 3

Similar threads

Top Bottom