The new Polish Act of 20 May 2010 on medical devices published on the 18th (...)
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MME News
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18 June 2011
NEW REGISTRATION REQUIREMENTS FOR MEDICAL DEVICES IN POLAND
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15 March 2011
CLINICAL INVESTIGATIONS: European Commission Publishes two New MEDDEV Guidelines
Changes introduced by Directive 2007/47/EC amending Council Directive (...)
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15 January 2011
THE CERTIFICATE OF FREE SALE FOR CE-MARKED MEDICAL DEVICES
QA/RA Directors of US manufacturers of Medical Devices may receive a (...)
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15 October 2010
Last News regarding the Reprocessing of Single Use Devices in EU
Today few countries in EU allow the reprocessing of single use medical (...)
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15 June 2010
Classification of medical devices : The New MEDDEV Guidelines has just been published
In the MME News of last March, we sent a warning that Annex IX of the (...)
Last News
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20 August 2019
August 21st Update - NANDO and MDR Notified bodies
August 21st 2019 - Latest news from NANDO concerning future "MDR-NB".
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18 August 2019
Additional guidance released _ Vigilance
Vigilance reporting : Latest release to provide further guidance to the use of new MEDDEV forms to be used no later than Jan 01, 2020
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10 July 2019
About SRN request by Notified Bodies
2019-07-10 _ About SRN request by Notified Bodies
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1 July 2019
Guidance about PPRC
Guidance on Article 15 - MDR_IVDR PPRC Person Responsible for Regulatory Compliance
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1 April 2019
Brexit _ UKCA marking April 01, 2019 Update
Using the UKCA marking if the UK leaves the EU without a deal.
GOV-UK - April 01, 2019 publishing
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