Europe – MDCG 2022-4 Rev.1 Guidance on appropriate surveillance regarding the transitional provisions under...
Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that
devices which are covered by valid certificates issued by a notified...
Switzerland – Switzerland, too, extends medical device certifications to safeguard supply
Switzerland plans to extend the certification of medical devices to match changes in the EU and reduce the risk of supply disruption.
Recently, the EU...
UK – MHRA joins international partnerships to set global standards for medicines and medical...
The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, the...
Europe – 34ème Organisme Notifié
ENTE CERTIFICAZIONE MACCHINE SRL
Via Ca’ Bella, 243/A - loc. Castello di Serravalle
40053 Valsamoggia (BO)
Country : Italy
Europe – MDCG 2023-2 List of standard fees
Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish...
Europe – The European Medical Technology in Figures 2023
Capturing the activity of the medical technology industry is vital for healthcare stakeholders, business leaders and policymakers.
Updated regularly, this platform draws on data from...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
Europe – MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed...
Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)...
UK – Register medical devices to place on the market
All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in...
UK – Impact of extension of Medical Device Regulations transitional period and the validity...
The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation (“EU MDR”). The proposal recognises the challenges in capacity across...
