| 24.10.2003 | | DGM obtains FDA Accreditation
DGM is now accredited by the Food and Drug Administration (FDA) to conduct medical device quality system inspections of eligible manufacturers of Class II and III devices under the Inspection by Accredited Persons Program, in place of an FDA inspection. The program is established by section 201 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). Read more here.
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| 27.02.2006 | | Reduce time and cost by using DGM as your Notified Body in Taiwan
If your company is exporting medical devices to Taiwan you will be happy to learn that DGM has been designated to be a partner in the Technical Cooperation Programme on exchange of audit reports between the EU and Taiwan. Using DGM as your Notified Body in this programme you can reduce time and cost in demonstrating compliance with regulatory requirements. |
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| 23.11.2005 | | Is your company ready for transition to ISO 13485:2003?
All manufacturers of medical devices must complete the transition to ISO 13485:2003 in the very near future. Has your company made its plan for transition to the new standard? |
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| 23.11.2005 | | Revision of the Medical Devices Directive 93/42/EEC
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| 22.09.2005 | | DGM now approves medical devices for fertilization
DGM’s notification has just been extended to include medical devices for fertilization. |
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| 19.04.2005 | | DGM introduces product sheets
DGM now introduces a series of product sheets with the purpose of disseminating useful information to our customers. The product sheets are used partly for describing our services, partly for giving an overview of subjects related to medical devices, regulatory requirements and certification which are notoriously difficult to handle.
You will find the following product sheets on our website under "Documents":
- CE marking of in vitro diagnostic medical devices
- CE marking of medical devices
- CE marking – how to get started
- Transfer of certificates to DGM
- Own Brand Labelling
The list of products sheets will be supplemented currently. |
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| 23.11.2005 | | Revision of Statutory Orders concerning Medical Devices and In Vitro Diagnostic Devices
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| 01.10.2004 | | DGM's new Business Unit Manager gives customer service top priority
“Faster case handling for our customers”, Arvid R. Bruhn announces straightforwardly. On 1 October 2004 he took up the position as Business Unit Manager responsible for DGM. |
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| 22.07.2004 | | Extension of DS/DGM IVD Notification
DS/DGM's IVD notification has now been extended to also including products for determining the following blood groups: AB0 system, rhesus (C, c, D, E, e) anti-Kell.
DS/DGM is the first body in Scandinavia notified for issuing approvals in accordance with the IVD directive. DGM is already notified to approving devices such as HIV test kits, test kits for Hepatitis B and C, reagents for the detection of rubella and toxoplasmosis, cytomegalovirus and the tumoral marker:PSA.
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| 17.05.2004 | | Accreditation to DS/EN ISO 13485:2003
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| 13.04.2004 | | DGM Newsletter 1/2004
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| 16.06.2003 | | DGM course programme Autumn 2003
DGM's course programme for the autumn 2003 is now available under "Courses". |
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| 10112003 | | Courses spring 2004
The courses for the spring of 2004 are listed under "Courses". More courses are on their way.
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| 05.09.2003 | | News from the Danish Medicines Agency
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| 01.07.2003 | | Courses - autumn 2003
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| 26.03.2003 | | Correction to newsletter
In the newsletter No. 1 of March 2003 an error has unfortunately crept in in the table New versions of standards - Are you up-to-date?
The dates of cessation of presumption of conformity of the superseded standards concerning EN 46001:1996 and DS/EN 46001:1999, EN 46002:1996 and DS/EN 46002:1999 and EN 1441:1997 and DS/EN 1441:1999 should all be in 2004 instead of 2003. See corrected table in the link. |
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| 26.03.2003 | | New newsletter about the certification of medical devices
Welcome to our first newsletter about the certification of medical devices.
You may rightly ask "Do we really need yet another newsletter in the constant flow of information that fills the workday lives of most people?" In this case, we believe the answer is yes.
Certification and approval of medical devices is undergoing a rapid process of change, and our intention is to create a news mdium that will help our customers and clients keep abreast of developments. |
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| 11.03.2003 | | DGM approved as EU CAB
The American Health Authorities FDA has now given their final approval that DGM can operate as an EU CAB (Conformity Assessment Body) under the American MRA (Mutual Recognition Agreement).
For manufacturers of medical devices in Europe this approval means that they can now approach DGM which on behalf of the FDA can perform 510(k) reviews and quality system inspections.
Please contact Anne Klitgård at +45 39 96 64 00 or akl@ds.dk for further details.
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| 04.03.2003 | | Nomination of DGM as Conformity Assessment Body in Switzerland
The Danish Ministry for the Interior and Health has just informed us that DGM has been nominated as Conformity Assessment Body (CAB) in pursuance of the existing MRA (Mutual Recognition Agreement) with Switzerland .
This means that DGM as of today can approve medical devices for marketing on the Swiss market.
If you require further information, please contact Anne Klitgård at phone number +45 39 96 64 00 or akl@ds.dk. |
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| 13.02.2003 | | Reclassification of breast implants
Commission Directive of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices.
Read more: |
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| 06.12.2002 | | Canadian Medical Device Conformity Assessment System (CMDCAS)
Manufacturers of medical devices, and distributors of such products acting as manufacturers according to the definition of the Canadian Medical Device Regulations, selling their product to the Canadian market, must as part of the requirements to obtain and maintain a medical device licence from Health Canada, be registered by a Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrar.
Our partner, Quality Management Institute (QMI), has now been accredited to provide registration to ISO 13485/8 as a CMDCAS recognized Registration Organization.
As a CMDCAS qualified Registrar, QMI can assist you to gain access to the Canadian market.
Through our partnership with QMI, DGM has been able to qualify and provide auditor resources for CMDCAS, and to perform audits to ISO 13485/8 under the CMDCAS requirements |
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| 29.11.2001 | | DGM Course Programme Spring 2002
DGM's course programme for the spring 2002 is now available under "Courses". |
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| 24.09.2002 | | Extension of DGM Accreditation
DGM's accreditation has been extended, so now we offer accredited certification to EN ISO 9001:2000 of companies' quality assurance systems. |
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| 30.05.2002 | | Extension of DGM IVD notification
DGM's IVD notification has now been extended to also including HTLV I and II.
DGM is the first body in Scandinavia notified for issuing approvals in accordance with the IVD directive. DGM is already notified to approving devices such as HIV test kits, test kits for Hepatitis B and C, reagents for the detection of rubella and toxoplasmosis, cytomegalovirus and the tumoral marker:PSA.
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| 17.01.2002 | | New Director of DGM
Mrs Anne Klitgaard, BSc Chem takes up the position as Director of DGM as per 1 February 2002. Anne Klitgaard comes from a position as quality and environmental manager of Maersk Medical.
Soren Sorensen continues as certification manager responsible for the technical aspects of DGM's certifications. |
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| 02.01.2002 | | DGM issues IVD certificate No. 1
DGM just issued our first certificate for CE marking of IVD devices to the Dutch company Organon Teknika b.v. |
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| 02.01.2002 | | DGM's price list 2002 is now available on our website
See "Documents" |
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| 29.10.2001 | | DGM receives yet another notification
As the first notified body in Scandinavia, Danish Medical Devices Certification (DGM) has now been notified by the Danish Ministry of Health for issuing approvals in accordance with the IVD Directive. In this directive, the EU lists the requirements to be fulfilled as regards the free marketability in Europe of in vitro diagnostic products. These products include HIV test kits and blood group determination products. |
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| 19.04.2001 | | The documents on DGM's homepage
The document section of DGM's homepage has been updated and been made more user-friendly. |
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| 09.04.2001 | | Notified Body Recommendation NB-MED Consensus statements - issue 02/2001
The document "Consensus statements" of Notified Bodies Medical Devices on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC" can now be downloaded from DGM's homepage. |
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| 22.06.2000 | | The Essential Requirements Checklist, BL 2.2-004 E
The Essential Requirements Checklist, BL 2.2-004 E, has been updated. |
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| 20-06-2000 | | Guidelines for the classification of medical devices.
This document is a revision of an earlier document published in March 1996 as MEDDEV. 10/93 rev. 5 |
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| 20-06-2000 | | Guidelines on a medical devices vigilance system
New draft working document released by the EU Commission 6 June 2000. |
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| 20.06.2000 | | Notified Bodies Recommendations have been updated
The Notified Bodies recommendations have been updated and three recommendations have been added. |
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| 21.02.2000 | | Danish order concerning in vitro diagnostic medical devices
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| 11.02.2000 | | New link to List of Harmonized Standards
In the section "Links" you now find a link to the "List of Harmonized Standards" on the website of the European Commission. |
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| 09.02.2000 | | ISO 13485/488 to be revised for adaptation to ISO 9001:2000
An ad hoc writing group composed of selected members of ISO Technical Committee (TC) 210, Working Group (WG) 1, Application of qulaity systems to medical devices, and the Global Harmonization Task Force (GHTF), Study Group (SG) 3, Quality system requirements, met at the Medical Devices Agency in London, December 6 to 8, to begin the revision of:
- ISO 13485:1996, Quality systems - Medical devices - Particular requirements for the application of ISO 9001 and
- ISO 13488:1996, Quality systems - Medical devices - Particular requirements for the application of ISO 9002.
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| 03.02.2000 | | Transition Arrangements for ISO 9001:2000
The International Accreditation Forum (IAF) has met with representatives from ISO/TC 176 to agree on transition arrangements for implementing the new standard. |
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| 03.02.2000 | | New DGM Lead Auditors
DGM has designated 4 new lead auditors to work in the medical device field on the US market. |
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| 03.02.2000 | | DGM to become Conformity Assessment Body, CAB
At the end of 1999 DGM submitted an application to the Danish Ministry of Health to become Conformity Assessment Body, CAB under the Mutual Recognition Agreement (MRA), between the European Union and the United States of America. |
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