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Whether you are a small start-up, requiring an effective regulatory watch or a mature company looking for detailed…
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Hot Topics
The date of application of MDR is 26 May 2020. If you are planning to benefit from transitional provisions defined on Article 120, you should check MDCG 2019- 10 for further details…
The Medical Device Single Audit Program (MDSAP) is led by Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW.
This revision of the standard provides a basis for the quality management system in parallel to the EU MDR’s and other international regulatory changes which occurred since the second revision of the standard.
PMA process is generally known as a 510K application and is frequently used by manufacturers wishing to enter the market.
Latest News
Software Guidance for MDR & IVDR
Software Guidance For MDR & IVDR The EU Commission has issued a new guidance document for use with the EU 2017/745 MDR and EU 2017/746 IVDR.This document, MDCG 2019-11, contains information on the qualification and classification of medical device software.You can reach MDCG 2019-11 from this link. Recent News
The Number of Notified Bodies is increasing
The Number of Notified Bodies is Increasing The EU Commission has authorized today the first notified body for the EU IVDR 2017/746 after the 5 notified bodies which were authorized for the EU MDR 2017/745. With 7 months till the date of the application of MDR, 5 organizations started the certification process. Although the EU […]
MDCG 2019-10 Article 120 Guidance
MDCG 2019-10 Article 120 Guidance The guidance document for the implementation of Article 120, which many companies plan to use during the transition to MDR EU 2017/745, has been published. The main requirements for the validity of the 93/42/EEC and 90/385/EEC certificates after May 2020 can be summarised as; No significant changes on the device […]
EU Comission Factsheet for IVDR
EU Commission Factsheet for IVDR EU Commission issued a Factsheet for Manufacturers of In-Vitro Diagnostic Medical Devices. If you still not defined your strategy for transition to IVDR (EU 2107/746), you may benefit from the factsheet issued recently by EU commission. Although the date of application of the IVDR is 26 May 2022, the high […]
Latest Articles
PMS, PSUR, PMCF
POST MARKET SURVEILLANCE New requirements for post market surveillance for Medical Devices. How to interpret the Annex III of the EU 2017/745(MDR) and EU 2017/746 (IVDR) Post Market Surveillance (PMS) requirements are impacted with the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR). PMS requirements for manufacturers are described […]
MEDICAL DEVICE SINGLE AUDIT PROGRAM
MEDICAL DEVICE SINGLE AUDIT PROGRAM The Medical Device Single Audit Program (MDSAP) is led by Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer’s quality management system that will satisfy the requirements of the medical […]
A SHORT GUIDE FOR MEDICAL DEVICE START-UPS
A SHORT GUIDE FOR MEDICAL DEVICE START-UPS: HOW TO CE MARK YOUR MEDICAL DEVICE IN LINE WITH THE NEW MDR REQUIREMENTS? The current medical device directive 93/42/EEC will be obsolete after 26th May of 2020.Medical Device start-ups, which plan to put their device after this date, will face the challenges brought by the MDR (EU 2017/745). […]
MEDICAL DEVICE REGULATION EU 2017/745
MEDICAL DEVICE REGULATION The long journey which has started in 2012 has finally come to an end and the long awaited text has been issued on 5th May 2017. The MDR 2017/745 will replace the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), whereas 2017/746 will be replacing 98/79/EC. The Regulations entered […]