Is there an Official Website for Medical Device Registration Information

L

LearnMo

#11
Note that the database is still defined and will be operative on 1st may 2011, see the EU decission which establishes the European databank for medical devices EUDAMED

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:102:0045:0048:EN:PDF

The information which will be available in the database is also defined:
1. Actor (manufacturer/authorised representative): (a) Name; (b) Street; (c) Locality; (d) Postcode; (e) Country; (f) Phone or E-mail; (g) Role.
2. Device: (a) Internationally recognised nomenclature code (for data generated after 1 May 2011); (b) Device Name/Make or, where not available, generic name.
3. Certificate (of the Notified body): (a) Certificate number; (b) Certificate type; (c) Date of Issue; (d) Expiration Date; (e) Manufacturer and, if applicable, authorised representative (see fields under 1. Actor); (f) Notified Body (selected from system); (g) General Scope description and, where applicable, details on device (see fields under 2. Device); (h) Status and, where applicable, reasons for decision of Notified Body.

Regards

Xavier Canals

But I have learned that the EUDAMED is not accessible to the public:nope:.
 
Elsmar Forum Sponsor
P

Persson - 2010

#12
The reason there is no such site, is as mentioned MIREGMGR, because of EC device regulatory system - Article 20 of MDD 93/42/EEC which maintained that all information available under the Directive is confidential. That's why you can see in some websites of NBs the ISO 13485 certificates, but not the certificates issued under MDD 93/42/EEC.
(BTW, Under the revised MDD (Article 20) confidentiality is no longer requested for: information in and about certificates, registrations of persons responsible, information to users in case of an incident).

As MIREGMGR suggested, some companies publish the CE certificates in their website. In the case you cannot find the certificates, you can look for other documents that usually bear the CE Mark like: product specification/datasheet (there maybe a paragraph for regulatory approvals/clearances), marketing materials, user manual, etc.
Attached is the Confidentiality Statement on the registration certificate issued by UK Medicines and Healthcare products Regulatory Agency MHRA to us via our EC Rep, Wellkang. Hope it helps!
 

Attachments

Last edited by a moderator:
P

Persson - 2010

#13
The reason there is no such site, is as mentioned MIREGMGR, because of EC device regulatory system - Article 20 of MDD 93/42/EEC which maintained that all information available under the Directive is confidential. That's why you can see in some websites of NBs the ISO 13485 certificates, but not the certificates issued under MDD 93/42/EEC.
(BTW, Under the revised MDD (Article 20) confidentiality is no longer requested for: information in and about certificates, registrations of persons responsible, information to users in case of an incident).

As MIREGMGR suggested, some companies publish the CE certificates in their website. In the case you cannot find the certificates, you can look for other documents that usually bear the CE Mark like: product specification/datasheet (there maybe a paragraph for regulatory approvals/clearances), marketing materials, user manual, etc.

Per the Article 20(2) of Directive MDD 93/42/EEC of 14 June 1993 as amended by: Directive 2007/47/EC of 5 September 2007,
the following information shall not be treated as confidential:
(a)
information on the registration of persons responsible for placing devices on the market in accordance with Article 14 of MDD 93/42/EEC;
(b)
information to users sent out by the Manufacturer, authorized representative or distributor in relation to a measure according to Article 10(3) MDD 93/42/EEC;
(
c)
information contained in certificates issued, modified, supplemented, suspended or withdrawn.
 
Thread starter Similar threads Forum Replies Date
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
M Informational EU – Official position on EUDAMED delay Medical Device and FDA Regulations and Standards News 6
M Informational EU – Corrigenda for MDR and IVDR published in Official Journal Medical Device and FDA Regulations and Standards News 0
P Any official doc/spec on different types of Yield calculation? Manufacturing and Related Processes 0
Q IVD vs EMC OJ (Official Journal of the European Union) Harmonised Standard Conflicts EU Medical Device Regulations 1
QMMike New Trend of not seeking Official ISO 9001 Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
Q Compliance to EU Official Journal Harmonized Standards (MD/IVD products in EU) EU Medical Device Regulations 7
bio_subbu Official Journal of EU published two new RoHS Exemptions EU Medical Device Regulations 1
K May 16 2014 Official Journal of the European Union Publication - 60601-2-33 EU Medical Device Regulations 3
M Official EU Unique Device Identifier (UDI) Requirements EU Medical Device Regulations 3
T Official Language in EU required for Medical Device Labeling EU Medical Device Regulations 24
D Official Clarification of ECO, PDR, PCR Acronym Definitions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
B Official Journal Postings Summaries for Medical Devices EU Medical Device Regulations 16
M Change Control - How low do you go before making official changes? Document Control Systems, Procedures, Forms and Templates 8
S AS9102 FAI for part number with no official drawing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Howard Atkins Official TS answers from SMMT- Layout, System Audits, MR and Doc Control IATF 16949 - Automotive Quality Systems Standard 9
K Are ISO 9001:2008 and AS9100:2009 going to be the official dates used? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Official Languages of the European Community ISO 13485:2016 - Medical Device Quality Management Systems 2
K New AS9101 - The Coordination Draft. Not the Official Release - IAQG9101 standard AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 76
D Official Government Regulatory Body Vigilance Contacts to use for China and for India ISO 13485:2016 - Medical Device Quality Management Systems 4
Manix Who is the Official Publisher of the APQP and Control Plan Manual? APQP and PPAP 2
SteelMaiden It's official, I am a quality geek Coffee Break and Water Cooler Discussions 3
A Definition Major Non-conformance and Non-conformance - Looking for official definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 15
S EC Official Journal Harmonized Standards - Additional requirements? ISO 13485:2016 - Medical Device Quality Management Systems 3
CarolX Star Trek XI will begin filming this fall for Christmas 2008 release - It's official! Coffee Break and Water Cooler Discussions 10
Marc Intel-Macs owners now have an official second OS option - Windows XP After Work and Weekend Discussion Topics 10
S Is official MSA training required person performing calibration? IATF 16949 - Automotive Quality Systems Standard 6
Y Is there an official 6S Quality Management System? Is 5S being added to? Misc. Quality Assurance and Business Systems Related Topics 10
M 9K2K Training Method - Acceptable? E-mails as Official Training ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Sidney Vianna Official ISO Interpretations - A Formal Process for ISO9001 Interpretation Requests ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
T How long until we get 'Official Paper' Certificate? Registrars and Notified Bodies 6
Howard Atkins QS-9000 Interpretations - July 2002 and the Official Announcement of the Death of QS QS-9000 - American Automotive Manufacturers Standard 9
E QS 9000 Official Web Site? QS-9000 - American Automotive Manufacturers Standard 5
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
N Updating the website of the manufacturer EU Medical Device Regulations 1
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sidney Vianna IAQG News IAQG has a new website - December 2019 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
A Contraindication Safety Statement in website - Radiotherapy equipment Other Medical Device and Orthopedic Related Topics 1
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
Z Two Payment Identification Number (PIN) for the same order in DFUF website 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 15
M Informational USFDA Ethylene Oxide Sterilization for Medical Devices website Medical Device and FDA Regulations and Standards News 0
R Publication of user information in manufacturer website for medical devices Other Medical Device Regulations World-Wide 2
E EU MDR GSPR 23.1 information on website CE Marking (Conformité Européene) / CB Scheme 2
Ed Panek Website to ask FDA for guidance in Medical Device Industry? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Trouble with Europa website - Internal Server Error (March 2019) EU Medical Device Regulations 5
J How to look up Failure Modes on FDA website FMEA and Control Plans 4
M Medical Device News EC – Commission reply to a Petition “For a Compensation Fund for PIP Breast Implants and CE” from the website change.org Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom