22. Mai 2019
The EU Commission Website now also includes a second Notified Body under the 2017/745: TÜV SÜD Product Service Gmbh Zertifizierstellen TÜV Süd is qualified for the following Conformity assessment procedures: Annex X: Conformity assessment based on type examination Annex IX(I): Conformity assessment based on a quality management system Annex IX(II): Conformity assessment based on assessment of technical documentation Annex XI(A): Conformity assessment based on product quality assurance Annex...

15. Mai 2019
The Indian regulatory body: Drugs Controller General (India) Directorate General of Health Services FDA Bhawan, Kotla Road, New Delhi. published on the CDSCO Website a new classification list today: link to the list

30. April 2019
A third procedure simplifying the registration process in Brazil was introduced with the publication of the RDC 270/2019. All Class I products now just need a "NOTIFICATION" with ANVISA. The procedures for market access in Brazil are now: Class I - NOTIFICAÇAO Class II - CADASTRO Class III and IV - REGISTRO

01. April 2019
The latest publication "Auditing Organization Availability to Conduct MDSAP Audits" dated 2019-04-01 all of the thirteen AOs are no identified as "recognized". See also the previous post on MDSAP

01. April 2019
The GMDN Agency now opened a "Basic" account that allows search in The GMDN database without any charges. Only a user registration is necessary to create the online access. Further information is available on the GMDN agency website. However, you may search by product NAME but it will NOT show you the CODE unless you buy it! Searching for the CODE will show you the NAME and the detailed information. The previous paid accounts will remain available for the previous fees including extra services...

26. März 2019
Among the 14 corrections (in the english version) recently introduced to the MDR (EU) 2017/745 one has a major impact to the review of the Technical documentation

13. März 2019
The EUROPEAN COMMISSION published the first Corrigendum for the Medical Device Regulation (EU) 2017/745. The document includes 125 pages with corrections necessary in each of the official languages of the EU. The various translations include a different number of corrections: Languages with 10 corrections: CS, DE, LT,PL, FI Languages with 11 corrections: BG, DA, ET, EL, FR, GA, HR, IT, LV, HU, MT, NL, PT, RO, SK, SL, SV Languages with 14 corrections: EN The German Version of the document...

07. März 2019
As decided by the European Commission and the MDCG the "free of charge" Nomenclature System for entering the data for Medical Device into the EUDAMED Database will be the CND "Classificazione nazionale (CND) e internazionali". Link to the most current version (2018-03-13) of the CND (in Italian language) Link to the english version (2016-06-08) of the CND The nomenclature was initially published in 2007 for the registration of Medical devices in the Italian national database hosted by the...

02. Februar 2019
UK Government is prepared to introduce its own conformity mark in case of the Brexit that will be replacement of the CE-marking used within the EU.

29. Januar 2019
MDCG today published another guidance explaining more details on the Basic UDI-DI that will be relevant for the EUDAMED Database Manufacturer's Declaration of Conformity And the Technical Documentation MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI The core information included is: The Basic UDI-DI code value shall have maximum 25 characters A check digit/character must be part of the Basic UDI-DI Further guidance concerning the UDI was already published by MDCG...

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