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Vote Final version EU Medical Device In Vitro Diagnostic RegulationsThe Council of the European Union announced the publication on Wednesday February 22nd, 2017 of the final draft version for the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Both texts, respectively 566 pages and 477 pages, have been long-awaited and are now available for consultation.

 

 

 

 

 

 

Council Register - Medical devices


Council of the EU - Background Documents

Please click here to access the Position of the Council at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council on Medical Devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

Please click here  to access the Draft Statement of the Council's reasons.

Please click here  to access the Position of the Council at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

Please click here  to access the Draft Statement of the Council's reasons.

The Council is expected to adopt the two texts on March 7. 

 

The vote for the adoption of the EU MD and IVD regulations

The finalization of the draft texts marks the end of several years of intense discussions between the European Commission, the Council of the European Union and the European Parliament. With the anticipated adoption of both the MD and IVD regulations, Europe will be closing an important chapter; instigated early 2012 with the ambition to recast the entire European Medical Device Regulatory Framework.

The vote for the formal adoption of these texts is estimated to occur both on the Council and the Parliament sides during the first semester of 2017. The Council of the European Union is set to vote on March 7th, 2017, followed shortly after by the European Parliament vote, on March 20th, 2017. If the respective dates suffer no setback, we can safely assume that the final publication for both the EU Medical Device and In Vitro Diagnostic Regulations will be released no later than May 2017. Right now, the European Commission’ website confirms that each of the texts is reviewed to prevent any technical discrepancy; and the translation in all of the European official languages is ongoing.

The adoption of both the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will permanently revoke the Medical Device Directive 93/42/EEC, the Active Implantable Device Directive 90/385/EEC and the In Vitro Diagnostic Directive 98/79/EEC presently used by Medical Device manufacturers to put their products on the European Market. The transition to the MDR will begin right after the entry into force of the text and will last 3 years; with 2020 as the application date. The IVDR on the other hand will have a longer transition period, set to last 5 years with 2022 as date of application.

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