| MT Promedt Consulting - US Office Moves
(04/Feb/2010) |
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After many successful years in Salt Lake City, Utah, the US office of MT Promedt Consulting
expands and moves to a new location:
The new address is:
MT Promedt Consulting GmbH (US Office)
c/o Mr. Marlon Berrett
41 North Rio Grande Street #100
Salt Lake City, Utah 84101
Phone:+1-801 699 0765
Fax:+1-801 546 2917
E-Mail: marlonb@worldnet.att.net |
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| Italy Extends Registration Deadline
(10/Jan/2010) |
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The deadline for registering medical devices with the Italian Ministry's online database has now been extended from 31 December 2009 to 31 March 2010, meaning that manufacturers will have a further three months grace before they are not allowed to sell their devices in Italy.
The registration scheme applies to devices, kits and systems covered by the Medical Devices Directive and the Active Implantable Medical Devices Directive, with the exception of custom made devices and devices intended for clinical investigations. In Vitro Diagnostic Devices are covered by a different online registration scheme.
As a German company MT Promedt Consulting is officially authorized to perform product registration in Italy for European and Non-European manufacturers. |
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| Guidance Updates on Clinical Evaluation and Vigilance
(22/Dec/2009) |
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The European Commission has published revised versions of two guidance documents, available on its website.
A major rewrite of MEDDEV 2.7.1 (revision 3) on the subject of Clinical Evaluation aligns the document with the Global Harmonization Task Force (GHTF) guidance on the same subject (2007) and takes into account the revisions to the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) brought about by Directive 2007/47/EC.
A minor change to the Vigilance MEDDEV 2.12-1 (revision 6) is restricted only to technical modifications to Annex 3 (the 'Report Form - Manufacturer's Incident Report').
MT Promedt Consulting is providing full support in preparation of Clinical Evaluation and implementation of Vigilance systems according to the new MEDDEV guidelines.
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| EUCOMED Releases White Paper on Reprocessing
(22/Dec/2009) |
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EUCOMED (the European medical device industry association) has released a white paper entitled 'Eucomed White Paper on the reuse of single use devices' to present the viewpoint that effective Europe-wide provisions should be introduced for the reprocessing of medical devices labelled by their manufacturers as 'single use' with an emphasis on the importance of patient-safety aspects.
The paper comments that: "In much of Europe the practice is heavily discouraged, but not universally illegal; … Current EU directives do not prevent a so-called refurbishment industry from re-selling refurbished single use devices."
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| New Draft Documents by GHTF
(04/Dec/2009) |
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The Global Harmonization Task Force (GHTF) has published three draft documents for comment on its website. Two further documents in the Quality Management series have been issued, along with a discussion paper on unique device identification (UDI).
The draft guidance documents are:
SG4/N84R12:2009: Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 5: Audits of manufacturer control of suppliers;
SG3(PD)/N18R8: Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes.
The discussion document is entitled GHTF/AHWG(PD1)/N2R1: Unique Device Identification (UDI) System. In addition, the minutes of the last GHTF Steering Committee meeting, held in Toronto in May 2009, are also available from the website.
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