UK: MHRA extends CE marking validity
Medicines and Healthcare products Regulatory Agency (MHRA) extended the timeframe for the acceptance of CE-marked Medical Devices and in vitro diagnostic [...]
07 07 2023
07 07 2023
07 07 2023
07 07 2023
MEXICO: Registration renewal and amendment management procedure changed
La Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) published in the Diario Oficial de la Federación on 10/05/2023 the update [...]
07 07 2023
07 07 2023
EUROPE: MDCG Guidance on significant change in Medical Devices has been updated
On 12 May 2023, the revision to MDCG 2020-3 Rev.1 Guidance on significant changes regarding the transitional provision under Article 120 [...]
29 06 2023
29 06 2023
Management of Critical Suppliers in accordance with MDR/IVDR
This Whitepaper provides information and practical tips for the proper management of Critical Suppliers by MDR (EU) 2017/745 and IVDR [...]
30 05 2023
30 05 2023
MDR Extension: main dates and fulfilments
30 May 2023 General conditions the extension of the transition period Compliance with Directive 90/385/EEC or Directive 93/42/EEC. No significant changes [...]
11 05 2023
11 05 2023
AUSTRALIA: faster registration if there is authorisation in Singapore
On 9 March 2023, the Australian Therapeutic Goods Administration (TGA) decreed that the Health Sciences Authority of Singapore (HSA) - Singapore's [...]
11 05 2023
11 05 2023
UK/SWITZERLAND: MDR extension impact
On 28 and 29 March 2023, the British and Swiss governments announced that the extension period in the manner set out [...]
11 05 2023
11 05 2023
EUROPE: Q&A guideline clarifies third MDR extension
On 28 March 2023, the European Commission published in the Official Journal of the European Union the guideline Questions&Answers (Q&A) entitled [...]
03 05 2023
03 05 2023
MDR extension: assumptions and practical application
3 May 2023 After the third extension of MDR (EU) 2017/745, formalised by Regulation 2023/607, it is increasingly difficult for manufacturers [...]
21 04 2023
21 04 2023
Miriam Cangi – Project Manager of Thema
Miriam Cangi, Project Manager of Thema, answered some questions about her work and role, also giving us valuable advices. Let's know [...]
