EUROPE: MDR Annex XVI Common Specifications’ draft Act approved
Last 13th October, with much anticipated vote, the Medical Devices Committee of the European Commission voted on the draft Implementing Act [...]
15 12 2022
15 12 2022
22 11 2022
22 11 2022
BRAZIL: ANVISA updates market access requirements for Medical Devices
Last 15th September, ANVISA (Agência Nacional de Vigilância Sanitária), the Regulatory Authority of the Medical Devices and IVD market in Brazil, [...]
22 11 2022
22 11 2022
CHINA: no more paper registration certificates
Last 26th October, the Center for Medical Device Evaluation (CMDE) of the di NMPA (National Medical Products Administration) issued the Notice [...]
22 11 2022
22 11 2022
ITALY: Ministry of Health issues document on surveillance requirements
Last 11th October, the Italian Ministry of Health issued the document “Vigilanza sugli incidenti con i Dispositivi Medici” which provides specifics [...]
21 10 2022
21 10 2022
USA: FDA issues electronic template for 510(k)
On 22 September, FDA issued the Electronic Submission Template for Medical Device 510(k) Submissions, a document that provides specifications on electronic [...]
21 10 2022
21 10 2022
USA: FDA updates fees for 2023
On 5 October, FDA published the Medical Device User Fee Amendments (MDUFA), a document containing updates on the registration fees for [...]
21 10 2022
21 10 2022
EUROPE: Best Practice for Technical Documentation submission
Despite MDR coming into force in 2017 and fully enforceable on 26 May 2021, it is still unclear for medical device [...]
20 09 2022
20 09 2022
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 [...]
20 09 2022
20 09 2022
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 [...]
20 09 2022
20 09 2022
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 [...]
