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Visualizzazione post con etichetta European Medical Devices. Mostra tutti i post
Visualizzazione post con etichetta European Medical Devices. Mostra tutti i post
giovedì 13 settembre 2018

IMPLEMENTING THE NEW MEDICAL DEVICES REGULATION: INDUSTRY CALLS FOR SOLUTION TO ENSURE CONTINUITY OF CARE TO PATIENT

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MDD REGULATION TRANSITION TIME - STOP THE CLOCK (?) MedTech Europe   -  Original publisher MedTech Europe is calling on the Europ...
domenica 12 marzo 2017

MEDICAL DEVICES AND VITRO IN DIAGNOSTIC MEDICAL DEVICES REGULATION The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal

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From WebSite The recent  scandals  related to metal-on-metal artificial hips or  faulty silicone breast implants  have strength...
giovedì 28 luglio 2016

GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC – MEDDEV 2.7/1 revision 4 – june 2016

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EUROPEAN COMMISSION DG  Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies  Health te...
giovedì 21 aprile 2016

EU - MEDICAL DEVICES GUIDANCE

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From website The European Commission provides a range of guidance documents to assist stakeholders in implementing directives relat...
lunedì 13 luglio 2015

MEDICAL DEVICES: COUNCIL GETTING READY FOR TALKS WITH EP

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On 19 June 2015, the Council agreed the substance of its negotiating stance on two draft regulations aimed at modernising EU rules o...
mercoledì 10 settembre 2014

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

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Link> for pdf document
giovedì 7 agosto 2014

MEDICAL DEVICE IN EU - Information sheet (At 2012)

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martedì 5 agosto 2014

AUDITS AND ASSESMENTS PERFORMED BY NOTIFIED BODIES IN THE FIELD OF MEDICAL DEVICES - UNANNOUNCED AUDITS

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(For unannounced aduits see annex III) COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by not...