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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.
Medtech Insight: global medical technology news & analysis
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Topics Coronavirus FDA
Medtech Insight: global medical technology news & analysis
By Sue Darcey
The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.
Topics Approvals Clinical Trials Coronavirus Policy & Regulation
Medtech Insight: global medical technology news & analysis
As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.
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