skip to main content
Close Icon We use cookies to improve your website experience.  To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy.  By continuing to use the website, you consent to our use of cookies.
Informa pharma logo

Pharma Intelligence is part of the Informa Intelligence Division of Informa PLC

This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Pharma Intelligence Logo
Search Icon Pharma Report StoreRecommendationsProduct loginProductLogin
Global Search Configuration

Medtech Insight Updates On The European Commission

The European Commission’s recently updated rolling plan confirms that the EU implementing act on the reprocessing of single-use medical devices, needed for the implementation of the Medical Device Regulation (MDR) is “undergoing formal adoption” and that the expected date of adoption is November 2019. The draft implementing act is out for comment until 20 August 2019.

The rolling plan also reveals that, in total, the European Commission has received 52 applications for designation as a notified body under the new MDR and IVDR and that 33 joint assessments of these applicants by the designating authorities have been carried out. New designations, Medtech Insight notes, are starting to roll out slowly.

As expected in our summary of the last update to the rolling plan in April, the commission adopted an implementing act – on 6 June 2019 – on the designation of issuing entities that will be responsible for the assignment of Unique Device Identification to medtech products.

Now on the agenda for adoption during the third and fourth quarters of this year are the following:

 

Target Dates

Comments

Third Quarter 2019

 

Standardization request to EU standards organization to align medtech standards to new regulations.

Undergoing adoption procedure. Decision was expected by Q3 2019 although,Medtech Insightnotes, there are sometricky hurdles to be navigated around

 

 

Fourth Quarter 2019

 

Eudamed implementing act on definition of detailed arrangements necessary to set up and support database

In preparation

Eudamed independent audit report on Eudamed achieving full functionality

Audit is due to start in Q3/Q4 and be finalized by Q1 2020.

Common specifications for IVD Class D

These are needed in the context of the scrutiny mechanism for high-risk devices

Rules to facilitate fulfillment of tasks under IVDR by EU reference laboratories

Implementing act in preparation

Expert panel fees

Survey currently with members of European Commission group that helps with the implementation of the regulations, the Medical Device Coordination Group.

Also recently made available by the European Commission is a FAQ document explaining the Unique Device Identification System, which includes a useful timetable for deadlines for pacing UDI carriers on medical devices and IVDs.

Read also

;

Next steps

Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.

Start a free trial

Our team is always happy to hear from you. Please call us at:

  • US Toll-Free  : +1 888 670 8900
  • US Toll           : +1 908 547 2200
  • UK & Europe : +44 (20) 337 73737
  • Australia        : +61 2 8705 6907
  • Japan              : +81 3 6273 4260

Or please submit your inquiry via the form so that we can provide you the best possible customer service.
General enquiry

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now:

Shop now