FAQ Natural Cycles

What type of information has the Swedish Medical Products Agency requested from Natural Cycles for the assessment?
The assessment has focused on product safety, instructions for use and post market surveillance documentation in order to confirm if the product is in compliance with regulations. The assessment was based on parts of the certification documentation. The Swedish Medical Products Agency has also assessed monthly reports of unwanted pregnancies among active app users in Sweden, during a time period of 6 months.

Does this mean that Natural Cycles is now to be considered as a contraceptive?
This app is already approved as a contraceptive method since the EC-certification given in 2017.

Does the Swedish Medical Products Agency approve medical devices?
No. The Swedish Medical Products Agency is responsible for supervision of medical device products and their manufacturers.

Is it acceptable to allow contraceptive to result in 7 out of 100 users becoming pregnant during one year of use?
The individual’s choice of contraceptive should be made in dialogue with a midwife or doctor. That dialogue should contain information about possible risks and health effects and a discussion about the suitability of the specific contraception given the woman’s situation and age.

Is the Swedish Medical Products Agency still interested in reports about pregnancies during use or general inaccuracies with the Natural Cycles app?
Yes.

What happens now? Will the Swedish Medical Products Agency continue to monitor Natural Cycles?
The Swedish Medical Products Agency will continue to monitor reports of unwanted pregnancies and make sure that no unexpected changes of trends, given the expected number of unwanted pregnancies, will be shown.

 

 
 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information