EXPORTING MEDICAL DEVICES IN EUROPE? YOU NEED AN EUROPEAN AUTHORISED REPRESENTATIVE
This White Paper focuses on the figure of the European Authorised Representative (EU REP), who plays a fundamental role in the [...]
12 06 2022
12 06 2022
30 05 2022
30 05 2022
EUROPE: guidance MDCG 2022-6 and Significant Changes in Period Of Grace
MDCG 2022-6 guidance on Significant Changes to Legacy IVD Devices pursuant to Article 110(3) IVDR was published a few weeks ago. [...]
30 05 2022
30 05 2022
TURKEY: Customs Union Agreement to market Medical Devices
On 13 April 2022, the European Commission published the notice (Notice To Stakeholders) to regulate trade relations between Turkey and the [...]
30 05 2022
30 05 2022
BRAZIL: RDC 665/2022 for Brazilian Good Manufacturing Practice (BGMP) application
ANVISA -Brazilian Regulatory Authority - published the RDC 665/2022 (entered into force last 2May 2022). This resolution rewrites the BGMP (Brazilian [...]
02 05 2022
02 05 2022
MDCG 2019-9 guidance on the Summary of Safety and Clinical Performance updated
The Medical Device Coordination Group (MDCG) on 24 March 2022 released the updated guidelines on the Summary of Safety and Clinical [...]
29 04 2022
29 04 2022
INDONESIA: simplified registration process for class A devices
On 10 January 2022, the Indonesian Ministry of Health, following Regulation 14 of 2021, announced that it had introduced a simplified [...]
29 04 2022
29 04 2022
BRAZIL: UDI’s system deadlines and Software as Medical Devices requirements (SaMD)
BRAZIL: UDI’s systema deadlines and Software as Medical Devices requirements (SaMD) RDC Resolution No. 591/2021 came into force on 10 January [...]
13 04 2022
13 04 2022
UK: from the CE mark to the UKCA mark. What to do?
In just over a year, it will be definitively mandatory to affix the UKCA mark on Medical Devices and IVDs to [...]
13 04 2022
13 04 2022
Thema’s first 15 years
2022 is a special year for us at Thema as it is the 15th anniversary of our company. After many years [...]
29 03 2022
29 03 2022
MDCG: last guidelines on class D IVDs and legacy devices
Last month, the Medical Device Coordination Group (MDCG) published two important guidelines. MDCG 2022-3 “Verification of manufactured class D IVDs by [...]
