Notified Body audits -Class Ia medical device product

M

MedicalDevice

Involved In Discussions
#1
#1
Hey everyone.
I am currently in the process of closing an agreement with an EU Rep. since I am marketing some products outside of Europe and thus, I need an EAR.
Could you please inform me if a class Ia medical device product, needs to be audited (class I=self-declaration)? Or am I only required to have the technical files for it reviewed and approved by my European Authorized Representative?

Thank you in advance for your time and help!
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
MedicalDevice said:
Could you please inform me if a class Ia medical device product, needs to be audited
Click to expand...
(Under assumption that you meant IIa - I don't know what Ia means)

Yes, if that device is intended to be placed on the EU market, it will need to be certified by a NB, i.e. audited.

Having asked this question, I strongly advise that you either hire a knowledgeable employee to deal with regulatory affairs, or engage with a consultant. There will be many questions like this one, and more complicated, along your (legal) path to the market.
 
Last edited:
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#4
#4
Class I devices don't require external audit unless they have a measuring function or are provided sterile or are intended for reprocessing (cleaning etc.) after each use.

The MDR doesn't explicitly require the European Authorized Representative to review and approve your technical files, but it's apparently implied that they'd have no other choice if they wanted to comply with the MDR:
The mandate shall require [...] the authorised representative to perform at least the following tasks in relation to the devices that it covers:
[...]
(h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
Click to expand...
If no other external body (e.g. a NB) will vouch for the technical files actually meeting "the manufacturer's obligations under the MDR", I don't see any other way for the EAR to tell whether these obligations are met and thus whether they need to terminate.

Whether or not EARs are actually interpreting the MDR this way, I do not know.
 
Last edited:
Watchcat

Watchcat

Trusted Information Resource
#5
#5
My understanding is that a lot more liability (legal or regulatory, I don't know) has been allocated to the EARs under the MDR, so they are being far more diligent and demanding than previously. However, this liability may not come into play (legally or pragmatically) with Class I devices. On the other hand, maybe even more so, since no NB has the EAR's back. Anyone know?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Notified Body (NB) Audits of Sub-Contractors and Critical Suppliers EU Medical Device Regulations 35
Q Medical Device Notified Body Surprise Audits Required in 2014 EU Medical Device Regulations 31
P Notified Body Approval of Change EU Medical Device Regulations 2
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
A NB (Notified Body) Audit of Standards ISO 13485:2016 - Medical Device Quality Management Systems 3
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Watchcat "Disappeared" Linkedin Notified Body Rant EU Medical Device Regulations 2
R Notified Body for MDD 1Q20 - Florida Company Registrars and Notified Bodies 4
M Informational EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational EU – New notified body designated under the MDR – NB 1912 – DARE!! Services B.V. – Netherlands Medical Device and FDA Regulations and Standards News 0
N Customer asking if their notified body can audit us ISO 13485:2016 - Medical Device Quality Management Systems 5
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
Ed Panek CAPA against Notified Body? EU Medical Device Regulations 5
M Informational EU – First IVDR designated Notified Body – DEKRA Certification GmbH Medical Device and FDA Regulations and Standards News 0
N Regular meetings with Notified Body EU Medical Device Regulations 13
M Informational EU – New designated Notified Body under the MDR – TÜV Rheinland LGA Products GmbH Medical Device and FDA Regulations and Standards News 0
M Informational New designated Notified Body for Regulation (EU) 2017/745 (MDR) included in Nando – IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Medical Device and FDA Regulations and Standards News 3
M Informational EU – Next Notified Body designated to the MDR 2017/475 is IMQ S.p.A from Italy Medical Device and FDA Regulations and Standards News 0
M Informational EU – DEKRA Certification GmbH is the third Notified Body designated under the MDR Medical Device and FDA Regulations and Standards News 0
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
M Measurement Unit Rounding Nonconformity - Notified Body Audit Registrars and Notified Bodies 6
M Informational From RAPS – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’ Medical Device and FDA Regulations and Standards News 2
M Authorized Rep (AR), competent authority, NCA and notified body - Differences EU Medical Device Regulations 9
R How long to wait for Notified Body Response - Potentially significant change to a medical device CE Marking (Conformité Européene) / CB Scheme 6
M Informational New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen Medical Device and FDA Regulations and Standards News 1
shimonv Non-significant notice of change to notified body EU Medical Device Regulations 4
S Difficulty Finding A Notified Body for CE Marking - No Capacity Registrars and Notified Bodies 5
P Notified body located in an other country than manufacturing company ISO 13485:2016 - Medical Device Quality Management Systems 2
M BSI – Want to know more about the Notified Body? Registrars and Notified Bodies 0
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
M Medical Device News BSI achieves Designation for its Netherlands Medical Devices Notified Body EU Medical Device Regulations 2
C Attestation of QA certificate from foreign (EU) Notified Body Other Medical Device Regulations World-Wide 6
D Notified body - CE Certification Class 2a Products in India CE Marking (Conformité Européene) / CB Scheme 4
M Notified Body Involvement with Self Declared Products EU Medical Device Regulations 7
C QR Code on Medical Device Packaging and Notification to Notified Body EU Medical Device Regulations 1
H Clinical investigation - Role of Notified Body (NB) EU Medical Device Regulations 6
S Certification Body, Registrar, Notified Body - What is the difference? Registrars and Notified Bodies 3
D CE Mark with same NB (Notified Body)? CE Marking (Conformité Européene) / CB Scheme 4
Sam Lazzara Expedited, fast-track Notified Body Technical File reviews EU Medical Device Regulations 3
Sam Lazzara Notified Body CE Project Manager - Worst job ever? EU Medical Device Regulations 6
K Notified Body - Minor Nonconformances - They have withheld all certificates General Auditing Discussions 3
R Non-Conformity Report from Notified Body - MEDDEV Guide is not Legally Binding EU Medical Device Regulations 16
JoCam Required Frequency of Notified Body reviews of Technical Files EU Medical Device Regulations 6
R ISO 13485 Certificate Scope modified by Notified Body EU Medical Device Regulations 9
S Literature Search - Notified Body Had Questions About our Rationale CE Marking (Conformité Européene) / CB Scheme 9
C Class I Reusable Surgical Instruments - CE Mark with the Notified Body number EU Medical Device Regulations 14
R Which Notified Body to Choose in the EU EU Medical Device Regulations 7
C Moving to a different Notified Body Quality Manager and Management Related Issues 5
A What to expect in a Design Dossier Review for CE Marking by a Notified Body CE Marking (Conformité Européene) / CB Scheme 3

Similar threads

Top Bottom