US: FDA publishes user fee amounts for medical device manufacturers in 2021

The FDA has recently published the user fee amounts which will be collected from medical device manufacturers in fiscal year 2021. Meditrial is the partner for medical device manufacturers in the US. Reach out to Meditrial for clinical or regulatory assistance! The amounts are listed

2020-08-03T09:44:47+00:00August 3rd, 2020|Uncategorized|

US: FDA issues final guidance on multiple function device products

The FDA finalized a guidance for sponsors regarding the FDA´s review of medical products that contain both medical and non-medical functions. Meditrial has extensive experience with assisting sponsors in regard of FDA requirements for medical devices and software as a medical device. The new from

2020-07-29T10:55:55+00:00July 29th, 2020|Clinical Trial, Software, USA|

US: FDA exempts additional Class II devices from 510(k) requirements

The FDA ordered the exemption five types of Class II medical devices from 510(k) requirements. This decision aims at releaving manufacturers of those devices from some regulatory burden. Meditrial has extensive experience on regulatory matters relating to medical device in the US and can help

2020-07-23T09:15:54+00:00July 23rd, 2020|Clinical Trial, Compliance, USA|

The European Commission updates on MDR implementation

The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices according to transparency obligations under the regulation. Moreover, the

2020-07-20T08:41:47+00:00July 20th, 2020|Clinical Trial, Compliance, Europe, MDR|

EU agencies commends sponsors to ensure post-Brexit compliance with clinical trial rules

The European Commission together with the European regulatory agencies EMA (European Medicines Agency) and HMA (Heads of Medicine), released a statement to urge sponsors to comply with clinical trials rules after Brexit. The deadline for compliance is 31st December 2020. In details, the notice reminds

2020-07-13T13:04:24+00:00July 13th, 2020|Clinical Trial, Compliance, Europe|

US: FDA plans to resume on-site domestic inspections as of 20 July 2020

The Food and Drug Administration (FDA) announced the plan to resume on-site domestic inspections beginning the week of 20 July 2020. The resume process will be different in each state according to local rules and epidemiological situation. Moreovoer, a new risk assessment system will be

2020-07-13T08:20:10+00:00July 13th, 2020|Clinical Trial, Covid-19, USA|

UK: Changes to amendment submission to HRA/MREC

On 2 June 2020 changes were introduced in the Integrated Research Application System (IRAS) to the way amendments are notified to Research Ethics Committees and NHS/HSC in the UK: Project-based research should now prepare amendments using the Amendment Tool. Amendments should be submitted for review via online

2020-07-08T08:51:00+00:00July 8th, 2020|Clinical Trial, Europe, UK|

EU: Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices

The European Commission (EC) conducted a survey in order to quantify lead times for conformity assessment for the various routes by which COVID-19-related medical devices may be placed on the market in the EU and for which notified bodies need to be involved. “Each notified

2020-07-08T08:00:34+00:00July 8th, 2020|Covid-19, Europe|

The European Commission launched COVID-19 In Vitro Diagnostic Devices and Test Methods Database

The European Commission launched the JRC COVID-19 In Vitro Diagnostic Devices and Test Methods Database. The objective of this database is to collect in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices as well as in-house laboratory-developed

2020-07-07T12:25:10+00:00July 7th, 2020|Compliance, Covid-19, Europe|
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