How to register class IIA medical device accessories

#1
Our company designs, manufactures and distributes dental implants and the accessories for their placement.

We grouped our products for registration, and one of those groups contains only accessories that have the shared intended use "Transient reference point for the production of prostheses or attachment constructions.".
We have established their class as being IIa because they are either:
1) Invasive, reusable, transient use, goes through body orifice, does penetrate skin, not connected to class I active device => annex VIII, rule 6. or​
2) Accessory to a device that is invasive, reusable, goes through body orifice, does not penetrate skin, not connected to class I active device => annex VIII, rule 5.3.​
We consider these accessories not to be medical devices because they do not "alleviate or compensate an injury or disability" nor do they "replace or modify the anatomy" (article 2 definition 1). They only are temporary assistance.

So my questions:
- can you register accessories on their own or can only medical devices be registered?​
- can the standard registration procedure be used or is an alternative route required?​
Thank you in advance for your assistance.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
In the EU accessories to medical devices are regulated just like medical devices (same requirements and procedures apply, unless explicitly stated otherwise).

I'm currently not going into the question of whether or not classification as accessories (rather than devices) is correct in this case.
 
Thread starter Similar threads Forum Replies Date
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
A Need to register with CA for Class I (Non-Sterile and Non-Measuring) Medical Device EU Medical Device Regulations 4
Tagin Is SARS-CoV-2/COVID-19 on your risk register? Misc. Quality Assurance and Business Systems Related Topics 11
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
K Capturing local government development/planning activities in aspect register ISO 14001:2015 Specific Discussions 2
S Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949 ISO 14001:2015 Specific Discussions 6
Leandro Need to register Medical Devices in Canada (FDA, HC, CMDCAS...) Canada Medical Device Regulations 3
D Design developer - 21 CFR 807 - do we need to register? Other US Medical Device Regulations 0
MrTetris Informational Risk Register - Same hazardous situation, different severity of harms ISO 14971 - Medical Device Risk Management 7
C Do Distributors need to register with competent authorities in the EU? EU Medical Device Regulations 2
A Do I have to register with the FDA and pay fee? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H REACH Registration Requirements - Who is required to Register REACH and RoHS Conversations 1
Z Do we need a Risk Register for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
T Register of TS 16949 Certified Companies IATF 16949 - Automotive Quality Systems Standard 2
B List of Legislation - Legal Register for ISO14001 ISO 14001:2015 Specific Discussions 3
T ISO 9001:2015 vs AS9100D - Register to one or both Standards? Manufacturing and Related Processes 10
L In Venezuela, do I have to register Molecular diagnostics kits or IVD kits? Other Medical Device Regulations World-Wide 1
B Before new supplier register into ASL ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Get information into English about medical devices register in Serbia Other Medical Device Regulations World-Wide 2
B Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt Other Medical Device Regulations World-Wide 8
R Legal Register - Does anyone have an example of a legal register? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Risk Register template as per ISO 27001:2013 wanted IEC 27001 - Information Security Management Systems (ISMS) 9
C Should we register to ISO 9001:2008 or ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Do I need to Register with FDA? How shall my structure of processes look like? US Food and Drug Administration (FDA) 4
N How to register a non notified Medical Device in India Other Medical Device Regulations World-Wide 5
A Legislation Register in Dubai (Free Zone) ISO 14001:2015 Specific Discussions 1
I Feedback on an Environmental Aspects and Impacts Register Miscellaneous Environmental Standards and EMS Related Discussions 5
V What is the importance of a Risk Register? FMEA and Control Plans 3
L Examples of a Legal Register - Environmental ISO 14001 ISO 14001:2015 Specific Discussions 2
H Source for Compiling and Maintaining an EHS Legal Register Miscellaneous Environmental Standards and EMS Related Discussions 4
S MDR (Master Document Register) for Planning of Documents in Process Engineering Document Control Systems, Procedures, Forms and Templates 2
S Basic Environmental Aspects Register template wanted Document Control Systems, Procedures, Forms and Templates 1
G Combining Aspect Impact and Hazard Risk Register Miscellaneous Environmental Standards and EMS Related Discussions 8
I What information do you place in a "register"? Quality Manager and Management Related Issues 2
I Is a Register of Signatures Required by ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
R Risk Register, Risk Analysis and Risk Response/Treatment IEC 27001 - Information Security Management Systems (ISMS) 5
T What to include in our Legal Register? Miscellaneous Environmental Standards and EMS Related Discussions 8
AnaMariaVR2 FDA Global Clampdown: 8 Warning Letters - Failing to Register Plants US Food and Drug Administration (FDA) 0
T Legal Register Guidance - ISO 14001 ISO 14001:2015 Specific Discussions 7
J Quality Records Register Requirements - ISO 9001:2008 Records and Data - Quality, Legal and Other Evidence 31
N Nonconformance Register template wanted Document Control Systems, Procedures, Forms and Templates 5
A I want to register IVDs (CE) in Australia Other Medical Device Regulations World-Wide 3
T Six Sigma Register - Historical Body of Evidence Six Sigma 2
D Register of Legislation for Czech Law - Czech Republic Miscellaneous Environmental Standards and EMS Related Discussions 1
Similar threads


















































Top Bottom