Medical Device Registrations in Europe - Regulatory Affairs of Medical Devices

PPcricket

Starting to get Involved
#1
Hello....I have a quick question related to the regulatory affairs of medical devices.

Once you have your product CE marked, to sell your products into Europe, are there specific country requirements in terms of registration and notification to the relevant country authorities, or can products be sold without any further notifications in the EU.

Many thanks, P
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: Medical Device Registrations in Europe

There are national requirements.

I have some compilations which came in the RAPS EU book, but I don´t know if there´s one place to look for them on the net (if there is, can someone please share?), but you could also look at the websites of each country competent authority.

Regarding notifications, the directives have requirements for post-market surveillance and vigilance. You can also take a look at some MEDDEVs (http://ec.europa.eu/enterprise/medical_devices/meddev/meddev_index_en.htm) and NB-MEDS (http://www.team-nb.org/index.php?option=com_docman&task=cat_view&gid=22&Itemid=38)
 

somashekar

Staff member
Super Moderator
#3
Re: Medical Device Registrations in Europe

There are national requirements.

I have some compilations which came in the RAPS EU book, but I don´t know if there´s one place to look for them on the net (if there is, can someone please share?), but you could also look at the websites of each country competent authority.

Regarding notifications, the directives have requirements for post-market surveillance and vigilance. You can also take a look at some MEDDEVs (http://ec.europa.eu/enterprise/medical_devices/meddev/meddev_index_en.htm) and NB-MEDS (http://www.team-nb.org/index.php?option=com_docman&task=cat_view&gid=22&Itemid=38)
Also one must note that EU members have various language requirements specific to the country and medical device classification. The IFU / Manual / other informations must respect this. During the CE mark process you would have made a commitment towards respecting the language requirements.
 

Marcelo

Inactive Registered Visitor
#4
Re: Medical Device Registrations in Europe

Just remembered another point, depending on your product, there even might be other applicable directives. For example, for consumer products, the general product safety directive might also apply (Directive 2001/95/EC on General Product Safety).
 

Rocke

Involved In Discussions
#5
Re: Medical Device Registrations in Europe

Hello....I have a quick question related to the regulatory affairs of medical devices.

Once you have your product CE marked, to sell your products into Europe, are there specific country requirements in terms of registration and notification to the relevant country authorities, or can products be sold without any further notifications in the EU.

Many thanks, P
Hi P,

Yes, you need to notify the competent authority in each member country, where you are placing the product on the market.
A list of contact information is available here: http://ec.europa.eu/enterprise/medical_devices/ca/list_ca.htm

Note that the EU Commission is considering, within its proposal package for the compulsatory implementation of EUDAMED, the deadline of 1st May 2011 as the end of the transition period for the notifications under article 10.6 of the IVDD (I do not know the relevant article in the MDD).
So hopefully, by May 1st 2011 you will only need your European representative (I am assuming you are located outside the EU) to inform the authorities in their own country of new products or product changes. The national CA will update the EUDAMED database and the information will be available to all European countries.

Best regards
Camilla
 
S

SilverHawk

#6
Re: Medical Device Registrations in Europe

For those non-European manufacturers who wish to list and place their products in EU and looking to appoint an Authorised European Representative, I would recommended this one as follows :-

Mr. Doram Elkayam
Obelis S.A.
Belgium
Tel : +32(0)2 7325954
Fax: +32(0)2 7326003
Mobile: +32(0) 473 490130
Email : Deleted by Moderator
 
Last edited by a moderator:
Y

yana prus

#7
Re: Medical Device Registrations in Europe

Regarding the various language requirements specific to the country and device - professional use vs. non-professional - here you can find the specific requirements of the EC countries:

http://www.team-nb.org/Documents/MD...ements_for_Medical_Devices_update_Sept.08.doc

You can add this doc to the list of the applicable standards/documents or just mention it in the Translation procedure.

The Italian Ministry of Health has introduced registration procedures for medical devices in Italy. All medical devices introduced in Italy after May 1, 2007 must be registered according to the procedures before medical devices can be sold in Italy.
 
W

Watchwait

#8
Re: Medical Device Registrations in Europe

Following the last post regarding language requirements, the matrix provided by Yana was helpful. However, we are always faced with making a more detailed decision regarding labeling as it pertains to medical devices in the EU. We produce a device that has language issues in the following areas:

1. Physical labels attached to the product.
2. Printed material accompanying, but not attached to the product.
3. An electronic Users Manual embedded in the product software.
4. A keyboard
5. A graphic user interface (GUI)

The requirements for items 1 & 2 is typically straightforward. They either require printing in the native language - or they do not. Item 3 could fall into this same class. Item 4 becomes a bit less clear. Is it acceptable to provide an English keyboard when the users manual is in the native language? Most challenging is item #5 - the user interface, as it requires the most customized software. But again, we are not complaining about having to do the work, if in fact it is REQUIRED by the target country. The problem we (I) have is finding clear, documented requirements that speak to these issues. Even our Notified Body, when asked directly cannot cite applicable rereferences for this information. Any takers here...??
 
S

scamden

#9
Re: Medical Device Registrations in Europe

Since this discussion has to do with MDD, I figured I would solicit some help here as well - I am conducting a research initiative on the expected impact of the amendments to the EU's MDD (MDD 2007/47/EC or M5) and am hoping that some of you might take a few minutes to take my brief survey. It is 14 questions, and no longer than 5 minutes to complete - I will be publishing the results in an industry journal, and will also publish a white paper for industry colleagues as a thank-you for their participation in this initiative - if you have a few seconds and could help me out, I would greatly appreciate it! Here is the address where you can locate the survey (won't let me post a regular link - I am hoping any that read this can assume that I am missing the www part of the address: maetrics.com/news_events/maetrics-initiates-research-study-on-mdd-2007

Many thanks!
Sara Camden
 
M

MarkinCalifornia

#10
Re: Medical Device Registrations in Europe

I have the exact same questions as Watchwait. I would certainly appreciate if anyone has any guidance that they can provide, particularly with regard to #5 (i.e., the need for the GUI to be in the national language(s) of the target country. Thanks
 
Thread starter Similar threads Forum Replies Date
3 Israel: 1 Medical Device, Multiple Registrations = Possible? Other Medical Device Regulations World-Wide 3
Q International Medical Device Registrations Other Medical Device and Orthopedic Related Topics 4
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 2
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8

Similar threads

Top Bottom