Requirements for CE Marked Class I Medical Devices for EU and Canada

P

PMIN92618

#1
I am new to International requirements for Medical Devices. We have self CE marked our class 1 products. What are the requirements for EU and Canada? Labeling requirements? Are there specific countries in the EU that have additional requirements?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Re: What are the requirements CE Marked Medical Devices for EU and Canada?

Hi,

If you have CE marked your devices then you should have already met the applicable EU requirements, including those that relate to medical devices labelling; if you haven't done so then your CE marking is in breach of the EU regulation. Generally speaking, the only additional requirements (on top of the Medical Devices Directive - the MDD) that specific EU member states apply relate to registration. Some require registration above and beyond the minimum that the MDD requires. National language translations may be required in some EU member states, however those are still within the scope of the MDD, so I wouldn't consider them "additional".

Canada has its own requirements, see here.
 
B

Bigdubz61

#3
Re: What are the requirements CE Marked Medical Devices for EU and Canada?

The way I understand this situation is that if you want to sell a class 1 device in Canada, you don't need a Device License. As long as you have the Technical File and you are selling through a Canada -based Agent, you fulfill the requirements. Although I do stand to be corrected.
 
P

PMIN92618

#4
Re: Requirements for CE Marked Medical Devices for EU and Canada?

Thank you. We are using a Canadian distributor, so I believe we are ok on that end.

Is there a good site anyone can recommend that shows what the requirements are for different countries? I use the Emergo site quite frequently, are there others?
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Requirements for CE Marked Medical Devices for EU and Canada?

Thank you. We are using a Canadian distributor, so I believe we are ok on that end.

Is there a good site anyone can recommend that shows what the requirements are for different countries? I use the Emergo site quite frequently, are there others?
I don't think you will find anything more condensed than Emergo.

Other than that just Google "[country] medical devices regulations".
 

mihzago

Trusted Information Resource
#6
Re: What are the requirements CE Marked Medical Devices for EU and Canada?

The way I understand this situation is that if you want to sell a class 1 device in Canada, you don't need a Device License. As long as you have the Technical File and you are selling through a Canada -based Agent, you fulfill the requirements. Although I do stand to be corrected.
You still need an Medical Device Establishment Registration, unless you have a distributor and that distributor has an Establishment Registration. If your company distributes directly, then your company needs to register.
 

shimonv

Trusted Information Resource
#7
Re: Requirements for CE Marked Medical Devices for EU and Canada?

Thank you. We are using a Canadian distributor, so I believe we are ok on that end.

Is there a good site anyone can recommend that shows what the requirements are for different countries? I use the Emergo site quite frequently, are there others?
The developing countries are not well organized with English resources like FDA's "Device Advice". This plus frequent updates makes it a special challenge. Networking and professional forums like Elsmar is the key for successful global registration.

Shimon
 
Thread starter Similar threads Forum Replies Date
E Requirements for distribution of Class I and Class IIa CE Marked Medical Devices EU Medical Device Regulations 3
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
F MDD Article 12 Labeling Requirements for CE Marked Medical Device - Help CE Marking (Conformité Européene) / CB Scheme 4
M Requirements for Non CE-Marked product EU Medical Device Regulations 8
B Article 12 MDD... Procedure packs! Requirements to Repack already CE Marked Products EU Medical Device Regulations 4
P QA requirements for non CE-Marked Device participating in a Clinical Study EU Medical Device Regulations 1
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 3
I Addiotional National requirements for placing MD in the EU countries EU Medical Device Regulations 4
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 4
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 0
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
D IATF16949 - Interpretation of Customer Requirements clauses Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
S Customer Specific Requirements (CSR) not signed/approved IATF 16949 - Automotive Quality Systems Standard 17
B FCA US IATF 16949 Customer Requirements updates Customer and Company Specific Requirements 3
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Baby food manufacture - food safety requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 0
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K OEM specific requirements - PPAP was rejected by STA Customer and Company Specific Requirements 5
W Insulation requirements of BF type infant skin temperature probe IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
M IEC 61000-4-2: Requirements for coating declared as insulating IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
R AS9100 - 8.4.2 - Receiving Inspection Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Requirements for an MDD approved device after 26/05/2021 EU Medical Device Regulations 3
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
S Translational Requirements - Article 120 EU Medical Device Regulations 5
D Interesting Discussion Requirements for selling a Food product in USA Food Safety - ISO 22000, HACCP (21 CFR 120) 0

Similar threads

Top Bottom