Get In Touch:

September Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 03 September 2021 Regulations EU MDR 2017/745 on Medical Devices and EU IVDR 2017/746 on In Vitro Diagnostic Medical Devices contain important improvements among which stricter control for high-risk devices is implemented via a new pre-market scrutiny mechanism, reinforcement of the rules on clinical evidence...
Read More

October Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021 To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation introducing substantial changes in the regulatory framework for in vitro diagnostic medical devices, such...
Read More

November Newsletter

EUROPE EUDAMED Notified Bodies and Certificates Module – Relevant documents and information| 15 November 2021 Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates. Such i...
Read More

December Newsletter

EU REGULATIONS MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state s that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into servic...
Read More

January Newsletter 2022

January Newsletter – EU Regulations MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 In vitro diagnostic medical devices | 12 January 2022 This notice is addressed to manufacturers of In-Vitro Diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection1 who are based in countries outside the EU or the EEA and who place or intend to place the abovementioned devices on the EU market. It is intended to highlight a n...
Read More

February Newsletter 2022

February Newsletter: EU REGULATIONS MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 (February Newsletter 2022) Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state s that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), or the Medical Devices Dire...
Read More

March Newsletter

AUSTRALIA March Newsletter: Consumer/Patient information materials requirements | 02 March 2022 On 26 October 2017, the Australian government passed laws requiring implanted and active implantable medical devices to include patient information materials (patient information booklets and patient implant cards). More flexibility in information delivery was introduced by providing electronic formats. Manufacturers of all implanted devices in the ARTG (Australian Register of Therapeutic Goods),...
Read More

April Newsletter

AUSTRALIA Transitioning to the new Therapeutic Goods Advertising Code | 05 April 2022 The Therapeutic Goods Administration (TGA) is updating advertisers on the transitional arrangements for the 2021 Advertising Code, particularly regarding hard copy ad stock. On January 1, 2022, the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (2021 Code) went into effect. The Therapeutic Goods Advertising Code (No. 2) 2018 is repealed and replaced by the 2021 Code (2018 Code). Advertis...
Read More

May Newsletter 2022

EUROPEAN UNION (EU) Stricter rules for placing medical tests on the market | 25 May 2022 From 26 May 2022, new laws for in vitro diagnostic medical devices (IVDR) such as HIV testing, pregnancy tests, and COVID-19 tests are in effect. The guidelines will improve public health and patient safety for these devices, putting EU law in line with technological advancements and medical research progress. It also ensures equitable market access for manufacturers by unifying market access standards acros...
Read More

June Newsletter

EUROPEAN UNION (EU) – JUNE NEWSLETTER Guidance document on the implementation of EU Product Rules 2022 | 29 June 2022 The ‘Blue Guide’ on EU product rules 2022 (Document Number (2022/C 247/01). This June newsletter guidance discusses both non-food and non-agricultural products, referred to as products for use by consumers or professionals. It applies to medical and in-vitro diagnostic devices that comply with Regulation (EU) 2017/745 and Regulation (EU) 2017/746. It covers various topi...
Read More