CAMD aim to provide guidance on transitional provisions for manufacturers of medical devices and in-vitro devices under the new EU regulations.
Other Industries
General Data Protection Regulation – scope and main changes
Useful information on the scope and main changes introduced under the new European General Data Protection Regulation, entering into force in May 2018.
Ex-vivo tests: cosmetics without human testing
Find out more information on the European Directive increasing the safety requirements for cosmetic products.
Challenges When Designing a Mobile Medical App for Safe and Effective Use
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.
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.
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.
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.
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.