July 22nd, 2014 : Enter in force of the RoHS 2 Directive, What impact for the...
Starting July 22nd, 2014, if US Manufacturers of medical devices do not to fully comply with the RoHS 2 Directive, they will have to stop all their shipments in EU. In fact, their products should be...
View ArticleGuidance documents for CE marking
In order to save time for our customers, we have created series of PC files to help them to build their Technical files. We give them free of charge.These main documents are: Checklist of the documents...
View ArticleOfficial European notification/registration of devices
Since the installment of the European Databank for MD and IVD products in May 2011, we notify the French Competent Authority on a special bilingual form with English and French Instructions for Use....
View ArticleSome other services
FREE SALES CERTIFICATESFree Sales Certificates (FSC) are often requested for registration of medical devices in Latin America countries and Asia.On request of a customer, MediMark Europe prepares the...
View ArticleMedical Devices
In order to answer to the different levels of risks of Incidents associated with the various types of Medical Devices, MediMark® Europe proposes two different options for US Manufacturers.Services...
View ArticleRevision of the Medical Devices Directives: Where are we in 2015?
The European Commission published the proposed new European medical device regulations on September 26, 2012. At that time, it was expected by experts that the final wording of the regulation could be...
View ArticleKey addresses for basic information
MediMark Europe has selected very helpful links for finding easily the updated official European regulatory documents and to feed some other regulatory needs.MD, IVD, AIMD Directives : This site from...
View ArticleThe new Radio Equipment Directive (RED) 2014/53/EU
This new directive will be applicable from 13 June 2016 and aligns the previous directive with the New Legislative Framework for the marketing of product.The Directive ensures a single market for radio...
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May 2016: Revision of the Medical Devices Directives: Where are we ?
In order to reach an agreement for the MD and IVD final draft regulations, the 3 bodies - the European Commission, the European Parliament and the European Council have entered in a number of trilogies...
View ArticleThe consolidated negotiated texts for the medical device and the IVD...
The trilogue negotiations are completed and the proposal regulations could be presented by the Council to the European Parliament for a formal vote within the next months. If adopted by the Parliament...
View ArticleAdditional information to provide to ANSM for Class III and Implantable MDs -...
Starting July 1st, 2017, 'When Class III and Implantable medical devices are put into service in France, the manufacturers or their authorized representative shall transmit to ANSM, the French...
View ArticleThe Last Versions of the Future EU Regulations published on February 22, 2017
The Council has published on February 22, 2017 the last consolidated texts regarding the MD and IVD new Regulations. These can be considered now as the final versions.The European Council is set to...
View Article5 April 2017 - EU Parliament adopts new medical device and diagnostics...
5 April 2017 – The final vote of the European Parliament has endorsed the new Regulation on Medical Devices (MDR) and the new Regulation on In vitro Diagnostic Medical Devices (IVDR). The official...
View ArticleJuly 1st 2017: New Notification Rules in France for Class 3 and 2b...
Modalities for the transmission of the Summary of the Characteristics of the Device Medical to ANSMStarting July 1st 2017, additional information (mainly on clinical evaluation and PMS) is required by...
View ArticleMedical Devices
In order to answer to the different levels of risks of Incidents associated with the various types of Medical Devices, MediMark® Europe proposes two different options for US Manufacturers.Services...
View ArticleIn Vitro Diagnostic Medical Devices
In order to give flexibility to the IVD manufacturers for a progressive introduction of their product lines into the European Market, the fee structure is constituted of an annual administrative fee...
View ArticleNovember 2017 : Team-NB Notified Bodies members' intention to submit...
In the framework of the new Medical Device Regulations, you will find attached the Team-NB members' intention to submit their application to be designated against the new MDR and/or IVDR. There are...
View ArticleNew adverse event terminology to be implemented in Europe starting from 2Q 2018
The European Competent Authorities are keen to receive codified information on adverse events already ahead of the date of application of the upcoming IVD and MD Regulations. The adverse event codes...
View ArticleClass 1 Reusable Surgical Instruments : Mandatory Conformity Assessment by a...
The article 52 ( 7) of the new EU Medical Device Regulation 2017/745 requests the involvement of notified bodies for Class 1 Reusable Surgical Instruments.The involvement of a NB was only mandatory...
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