As application designers have begun taking advantage of the advancements of technology and the growing patient trend for self-diagnosis and treatment, regulators have begun scrutinizing mobile medical apps.
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Belgian Medical Competent Authority abolishes submission taxes
Belgian medical competent authorities abolish submissions taxes to help ease manufacturers' entry to the European market.
Not only UVA and UVB
The use of screens, smartphones and tablets expose the skin to blue light, that can lead to health issues. Find out how cosmetics can protect from blue and infrared light.
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.
Israel aligns with European cosmetics law
The Israeli Ministry of Health has announced new drafts of regulations called “Pharmacists’ Regulations (Cosmetics)” that mirror the European Regulation on cosmetics.
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.
Phthalates found in toys on the EU market
A recent ECHA study has found that a high number of toys on the EU market contain chemicals (DEHP, DEP, BBP) restricted by the European Union.
Preservatives in cosmetics
Find out more information on preservatives regulations on cosmetics.
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.