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 only 23 NB for the MDR and 11 for the IVDR.
Most recent articles
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November 2017 : Team-NB Notified Bodies members’ intention to submit application to be designated against the new MDR and/or IVDR
15 November 2017, by Rene Clement -
July 1st 2017: New Notification Rules in France for Class 3 and 2b implantable Medical Devices
13 June 2017, by Rene ClementModalities for the transmission of the Summary of the Characteristics of the Device Medical to ANSM
Starting July 1st 2017, additional information (mainly on clinical evaluation and PMS) is required by ANSM, the French national competent authority, in addition to the current notification for any new devices class 3 and class 2b implantables put on the market after June 30, 2017.
You will find attached a MediMark Free English translation of the requirements.
Since no form is available (…) -
5 April 2017 - EU Parliament adopts new medical device and diagnostics regulations
6 April 2017, by Rene Clement5 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 timings for transition start 20 days after the new laws are published in the Official Journal. This is expected in early May, which means an official transition starting date around the 1st of June. The Regulations will be fully applicable in three years for medical devices and in five years for (…)
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The Last Versions of the Future EU Regulations published on February 22, 2017
27 February 2017, by Rene ClementThe 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 vote on the regulations on March 7, and the European Parliament will vote on March 20. If passed, the regulations could become effective as early as May. Manufacturers would then have three years to comply with the MDR and five years to comply with the IVDR.
The Article 11 regarding the (…) -
Additional information to provide to ANSM for Class III and Implantable MDs - July 1st 2017
6 February 2017, by Rene ClementStarting 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 Competent Authority a summary of their characteristics and particularly (in bold) the information which are not generally in the IFU:
1°: Identification of the medical device, the manufacturer and, where applicable, the authorized representative:
a) The name or commercial name of the medical (…) -
The consolidated negotiated texts for the medical device and the IVD regulations are available
20 June 2016, by Rene ClementThe 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 in its second reading, the legislative texts could be published after the translations and the Legal review in the first months of 2017 coming into full effect three years later in 2020.
However, some changes can still occur with possible delays in implementation.
A critical point is the (…) -
May 2016: Revision of the Medical Devices Directives: Where are we ?
19 May 2016, by Rene ClementIn 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 which cover the main political issues regrouped in four blocks: Aesthetic devices, i.e. devices without a medical purpose (Article 1 and Annex XV MD, Block 1), In-house products (Article 4, Block 1), Liability insurance for manufacturers of devices (Article 8, Block 1), Implant card and (…)
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The new Radio Equipment Directive (RED) 2014/53/EU
31 March 2016, by Rene ClementThis 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 equipment by setting essential requirements for safety and health, electromagnetic compatibility and the efficient use of the radio spectrum. This applies to all products using the radio frequency spectrum.
The revision takes account of the need for improved market surveillance, in (…) -
Revision of the Medical Devices Directives: Where are we in 2015?
23 March 2015, by Rene ClementThe 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 published in early 2014, prior to the European Parliament elections, coming into full effect three years later in 2017.
However, in October 2013, the European Parliament adopted a lot of amendments to the initial EC regulations such as the creation of an Assessment Committee for Medical (…) -
July 22nd, 2014 : Enter in force of the RoHS 2 Directive, What impact for the US Manufacturers of medical devices ?
16 July 2014, by Rene ClementStarting 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 already into the EU distribution chain, e.g. already placed on the market at this date. Then, they could be sold to end users until July 29th, 2019.
The most common questions concerned the ROHS documentation, certification and the Declaration of conformity to this directive.