The assessment of Natural Cycles is completed

På svenska

On request of the Swedish Medical Products Agency, the manufacturer Natural Cycles has now clarified the risk of unwanted pregnancies in the instructions for use (IFU) and in the app. Thereby, the Swedish Medical Products Agency has no further remarks and the assessment is completed.

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, during a time period of 6 months.

“Our conclusion is that the number of unwanted pregnancies during the assessed time period is consistent with data shown in the clinical evaluation included in the certification documentation . Since it is important that a contraception app is correctly used, we requested the manufacturer to clarify the risk of unwanted pregnancies in the instructions for use and in the app. These issues have been addressed by Natural Cycles and thereby our review is completed”, says Mats Artursson, investigator at the agency.

Certified by third part
The product documentation review and EC-certification allowing the manufacturer to CE-mark the Natural Cycles app has been conducted by a Notified Body in Germany.  The Swedish Medical Products Agency is not responsible for medical device approvals, but is responsible for supervision of the products and their manufacturers. Following an increased number of vigilance reports in 2018 from health care providers regarding unwanted pregnancies when using Natural Cycles for contraception, the Swedish Medical Products Agency initiated an investigation.

During the first half of 2018, the Swedish Medical Products Agency has requested and received monthly trend reports from the manufacturer about the product’s performance when used in Sweden.

The following measurements have been reported:
– Number of registered users 
– Number of active users
– Number of unwanted pregnancies 
– Pearl Index (failure rate in typical use e.g. number of unintended pregnancies per 100 women and year)

Expected number of pregnancies
The investigation shows that the number of unwanted pregnancies and the Pearl Index is consistent with data shown in the clinical evaluation included in the certification documentation. The failure rate in typical use was 6.9% both in the clinical evaluation and in the 6 months post market follow up review.

Post market follow up in Sweden, January – June 2018:

 

January February March April May June
Unwanted pregnancies 110 101 112 121 120 112
Pearl Index 6.7% 6.7% 6.6% 6.6% 6.8% 6.9%

 

 

The clinical evaluation included in the technical file for Natural Cycles, that has been reviewed by the Swedish Medical Products Agency in the investigation, show that during one year 7 women out of 100 will be unwanted pregnant in typical use of the app as contraception method. 
 
Clarifying risk of unwanted pregnancy
The Swedish Medical Products Agency has requested the company to clarify the risk of unwanted pregnancy in instructions for use and in the app, so that it can be taken into account by users. Natural Cycles has had the possibility to express their views concerning remarks, and have chosen to make changes to comply with the remarks of the Swedish Medical Products Agency. The corrections have been presented to the Swedish Medical Products Agency which finds them acceptable. Thereby the assessment is completed.

Users who have concerns or questions about which contraception method that would be appropriate on an individual base, should contact a healthcare provider for assistance and advice.

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.