US: FDA issues guidance on ISO 10993-1 for the biological evaluation of medical devices

The U.S. Food and Drug Administration (FDA) has issued a guidance document on the use of ISO 10993-1 in the assessment of medical devices that come in direct or indirect contact with the human body. The standard is recognized by the FDA and can be

2020-09-25T09:08:43+00:00September 25th, 2020|Clinical Trial, Compliance, Regulatory, USA|

US: FDA “green lights” the path for ePRO through regulation

The FDA issued a guidance for the selection of patient-reported outcome (PRO) instruments in clinical evaluation of their products. The guidance details such topics as modification or adaptation of existing PRO instruments as well as the possibility of including patient-reported outcome instruments within real-world data

2020-09-03T08:40:47+00:00September 3rd, 2020|Clinical Trial, Compliance, Regulatory, Software, USA|

EU: EUDAMED actor registration module active as of December 2020

With the MDR, EUDAMED will act as central repository of information to lay the foundation for collaboration, transparency and interaction of all parties, namely the new European databank for medical devices and in vitro diagnostic devices. EUDAMED will have several modules and contain extensive data.

2020-08-31T15:54:45+00:00August 31st, 2020|Europe, MDR, USA|

EU: Common specifications for reprocessing single-use devices set by the European Commission

On August 19th, 2020 the European Commission implemented regulation as regard common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). Under the MDR, single-use devices may be reprocessed where permitted by national law. Reach out to Meditrial to know

2020-08-31T14:58:07+00:00August 24th, 2020|Compliance, Europe, MDR, Regulatory|

US: FDA issues provides specific perfomance criteria for cutaneous electrodes and some catheters

The FDA issued the first two device-specific guidances drawing performance criteria to support 510(k) clearance via the new pathway. The FDA had previously proposed an alternate safety and performance based pathway for certain well-understood medical devices. The two final guidances provide performance criteria for cutaneous

2020-08-17T08:34:29+00:00August 17th, 2020|Clinical Trial, Compliance, Uncategorized, USA|

UK: MHRA plans to restart on-site inspections as of September 2020

MHRA issued a guidance including the plan to resume on-site inspections next September and scale up to full on-site inspection program in October 2020. Onsite inspections in the UK halted in March due to the COVID-19 pandemic. If you have experienced any disruption to your

2020-08-14T10:04:40+00:00August 14th, 2020|Clinical Trial, Covid-19, UK|

US: The FDA answers device´s importers questions during COVID-19

The Food and Drug Administration has published two new webpages with instructions on medical device importation, registration and listing amid  COVID-19. Meditrial is there to help! - Reach out to us for any kind of assistance in regard of COVID-19 issues related to your device

2020-08-13T08:55:26+00:00August 13th, 2020|Clinical Trial, Compliance, Covid-19, USA|

EU: Medical Device Single Audit Program guidance by the EU Commission’s Medical Device Coordination Group

The EU Commission’s Medical Device Coordination Group issued a guidance providing details on how notified bodies can reference Medical Device Single Audit Program  audit reports when planning surveillance audits under the MDR or IVDR. Meditrial can help you to get your medical or in-vitro device

2020-08-11T13:37:18+00:00August 11th, 2020|Compliance, Europe, Regulatory|

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|
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