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EUROPE: MDCG 2022-14 | Immediate actions planned to facilitate transition to MDR/IVDR

To this date, it is still difficult for Manufacturers to embark on an MDR or IVDR certification pathway in a way that is clear, accessible, and that ensures continuity in device commercialization. For this reason, the MDCG Guideline 2022-14 Transition to the MDR and IVDR Notified body capacity and availability of Medical Devices and IVDs, [...]

2022-09-20T16:26:54+02:00September 20th, 2022|News|

EUROPE: published guideline on borderline devices according to MDR and IVDR

The published version 1 of the Manual on borderline and classification for Medical Devices under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices guideline is supportive in determining whether a borderline product falls under the definition of a medical device and under what classification rules. The document, [...]

2022-09-20T16:25:21+02:00September 20th, 2022|News|

ITALY: MDR/IVDR adaptation decrees in force

On September 28, 2022, the two decrees for the adaptation of Italian regulations to the provisions of MDR (EU) 2017/745 and IVDR (EU) 2017/746 will come into force and apply to all parties involved by the regulations (notified bodies, economic operators and healthcare operators). The two decrees are specifically Legislative Decrees No. 137 (Medical Devices) [...]

2022-09-20T16:23:22+02:00September 20th, 2022|News|

US: GUDID entry deadline extension for Consumer Health Products

Last July, 22 FDA published the guideline Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices which extends the GUDID database entry deadline for certain Class I and Unclassified over-the-counter devices. The subject of the document is precisely Consumer [...]

2022-08-11T09:12:16+02:00August 10th, 2022|News|

AUSTRALIA: published reference text for clinical evaluation

Through the document Clinical evidence guidelines for Medical Devices published last June, TGA has finally made available the most significant guidelines to allow Manufacturers and Sponsors the collection, drafting and submission of clinical evidence that complies with regulatory requirements and is in line with the requirements of TGA reviewers. The document, divided into three sections [...]

2022-08-11T09:13:15+02:00August 10th, 2022|News|

UK: possible extension of CE marking validity

In order to avoid a blockage of healthcare supplies in the territory, MHRA (Medicines and Healthcare products Regulatory Agency) is considering the possibility to postpone the requirement for affixing of the UKCA marking under certain unavoidable conditions. The scenario proposed as a result of the aforementioned assessment would amend of what has already been published [...]

2022-08-11T09:11:20+02:00August 10th, 2022|News|

THAILAND: preferential route for devices already registered in Singapore

On 20th June 2022, the TFDA (the Thai FDA) established the expansion of the Singapore Reliance Route programme, initially tested only with Class D/Class 4 products, to all Class B, C and D Medical Devices. Effective immediately and enjoying the preferential pathway, the Thai FDA will review applications in a maximum of 60 working days [...]

2022-07-26T16:38:09+02:00July 26th, 2022|News|

SAUDI ARABIA: UDI extended to 2023-2024

The SFDA (Saudi Food and Drug Authority, the Saudi Arabian Regulatory Authority for Medical Devices and IVDs) announced a one-year postponement of the requirements’ implementation for unique device identification, i.e., the UDI system. The extension and the corresponding timeframe for ensuring compliance with the UDI system are as follows: 1st September 2022 for class B, [...]

2022-07-26T15:59:44+02:00July 26th, 2022|News|

USA: platform status for 510(k) submission

The FDA is constantly recruiting personnel to test the Customer Collaboration Portal (CCP) functionality. This portal is already active to check the procedures status and it will soon be implemented for uploading Medical Devices pre-market authorization dossiers, including traditional, abbreviated or special 510(k) procedures. The uploaded documents can be in both eSTAR and eCopy formats. [...]

2022-07-26T17:31:02+02:00July 26th, 2022|News|

CHINA: updated safety standard for electroMedical Devices

Performing technical safety tests is a key step in the procedure for accessing the Chinese device market and is particularly critical in the case of electro-Medical Devices. This is because tests performed outside the Chinese border and their reports prepared in accordance with the international standard IEC 60601-1 are not recognised when applying for device [...]

2022-07-25T15:34:37+02:00June 21st, 2022|News|
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