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Basic UDI-DI, UDI-DI, UDI-PI, UDI ... It is easy to get in a complete muddle when using these codifications that are now required by EU Medical Device Regulation 2017/745. What are the differences between these codes? Which one should be applied d...
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Category: Regulatory affairs
The Essential Requirements of Directive 93/42/EEC become the General Safety and Performance Requirements (GSPR)
💡 The Essential Requirements of Directive 93/42/EEC become the General Safety and Performance Requirements (GSPR) under Regulation (EU) 2017/745. The requirements in the new regulatory text are expanded and more explicit but remain consistent with...
Lire la suiteNew service – UK responsible person
As part of the news encompassing Brexit, French manufacturers wishing to place medical devices to the Great Britain market must appoint a UK responsible person. Askorn offers a solution of UK responsible person and ensures for you the registra...
Lire la suiteISO 13485 certification, 2016 version
The quality management system developped by Askorn has been accepted as complying with the requirements of the 2016 version of ISO 13485 by the french notified body GMED. This is the first step towards MDR 2017/745 compliance. The scope of the cer...
Lire la suiteEU MD Regulation : the race to compliance
In a survey published by KPMG and the RASP (Regulatory Affairs Professional Society), more than 200 Quality and Regulatory Affairs managers were asked how prepared they feel regarding the coming EU MD Regulation. The companies that took part in the s...
Lire la suiteUS market access : the FDA may replace QSR with ISO 13485:2016
The Food and Drug Administration is considering replacing their actual Quality System Requirements (QSR) from 21CFR part 820 with the requirements from ISO 13485 version 2016. This is for the moment a proposition of rule modification, which should ...
Lire la suiteObligations of medical devices distributors
The MDR 2017/745 also impacts medical devices distributors, whose obligations and responsabilities grow. Distributors are now expected to verify the conformity of the products they place on European market, through the following documentary verti...
Lire la suiteNotification of bodies for new MD regulations
The european association of notified bodies for medical devices Team-NB published the list of member bodies that intend to submit an application to be designated against the new regulations. With no surprise, all 23 members of the association in...
Lire la suiteTeam NB : 2016 survey results
On May 9, 2017, the European Association for Medical Devices of Notified Bodies Team-NB published the results of its yearly survey run among its 21 members, in order to collect data on certificate emission and analyse the variation with previous yea...
Lire la suiteNetherlands : UDI for implantable MD from July 1st, 2018
On June 21, 2017, the Dutch minister of health signed an agreement with healthcare profesionnals and manufacturers in order to introduce an identification system for medical devices. It was agreed to adopt the FDA's UDI (Unique Device Identificat...
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