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...
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...
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...
Switzerland – Swissmedic prepares medtech industry for activation of medical devices database module
The first module of the swissdamed medical devices database goes online in August
Since the MRA with the EU has not been updated, Swissmedic does...
UK – UK regulator MHRA to raise medical device registration and other fees by...
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has published a consultation for industry comment regarding a proposed increase in fees the agency...
Europe – Manual on borderline and classification for medical devices under Regulation (EU) 2017/745...
Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of...
