Belgian medical competent authorities abolish submissions taxes to help ease manufacturers' entry to the European market.
Medical devices and healthcare
The impact of the new MDR and IVDR Regulations on Notified Bodies
The new MDR (2017/745) and IVDR (2017/746) will replace the EU’s current Medical Device Directive (MDD) (93/42/EEC) and In Vitro Diagnostics Directive (IVDD) (98/79/EC) to establish a more robust EU legislative framework and ensure better protection of public health and patient safety.
ISO 13485:2016 strengthens the control of suppliers in Medical Device Industry
ISO 13485:2016 aims to harmonise quality system requirements and ensure a higher degree of compliance with regulations amongst suppliers of medical devices.
Transitioning to ISO 9001:2015 & 14001:2015
Understanding new changes under ISO 9001:2008 and ISO 14001:2004 to help navigate the transition for manufacturers.
Clinical Evaluation for medical devices (many more requirements under MDR)
Learn about the changes introduced for clinical evaluations under EU medical device regulation 2017/745. Re-classification, comparative evaluations and more.
Saudi Arabia – SASO and CAP (Conformity Assessment Program) do not apply to Medical Devices – FSC is the best tool to enter this market
SASO CoC (Certificate of Conformity) and CAP (Conformity Assessment Program) are two particular Conformity Assessment routes that are allowing manufacturers worldwide to enter the market of Saudi Arabia with their products. This is in order to ensure some key objectives such as: Protection of public health, Consumer safety, National security, Protection of religious and public morals and environment, Prevention of deceptive practices.
Electronic cigarettes are to be regulated as medical devices if they do not contain nicotine
How can a manufacturer decide on the classification of their electronic cigarettes?
Find out how E-cigarettes need to be regulated in the EU Market.
Post-market surveillance under the MDR: New requirements
Post-market surveillance requirements are strengthened under new EU medical device regulation 2017/745. Find out what implications it has for your device.
New WEEE Directive 2012/19/EU (Waste of Electric & Electronic Equipments) is published
Learn more about the objectives and main amendments of new EU Waste if Electric & Electronic Equipments regulation 2012/19/EU.
Sanitary Certificates in Italy
In order to protect public health, shipments of goods of medical interest imported from third countries and arriving at the international entry points of the Italian territory are subject to controls by the National Medical Authority.
Read more on this topic here.