A client of mine recently asked me to help them plan a clinical study for a low-risk medical device. The company is located in the USA and they intend to launch the product is the USA first. At first I was shocked, because there was no clinical study requirement for the product in the USA. The product is a Class II device and the product classification has very minimal requirements for performance testing in order to demonstrate safety and efficacy. There is no recognized standard specific to the device, and none of the predicate devices (I checked 100% of them) has ever submitted clinical data.

So why did this company need help with a clinical study?

This client was a physician/inventor that had started a new company, and they said that none of their peers would recommend the product to their patients without some clinical data.

Reimbursement is not an issue for this product, because there is already a reimbursement code for the product. Testing required for a 510(k) submission is clearly defined, but without clinical data to demonstrate efficacy of a new product very few physicians will take a chance trying a new product.

My client also asked what would be required for regulatory approval in Europe and Canada. The Canadian Medical Device Licensing pathway for this product was very simple. The product is a Class II device in Canada. Therefore, only ISO 13485 certification and an application form are required for Canada.

Europe is somewhat more challenging for a few reasons:
1. All products must have a clinical evaluation
2. All products must have post-market clinical follow-up or a rationale why it’s not required
3. All products require a detailed risk management file in accordance with EN ISO 14971:2012

In the past, a company could perform a literature search for articles summarizing the results of clinical studies for similar products. The requirements for this approach recently changed. In the past “equivalent devices” were allowed, but now the “equivalence” is defined and it is very difficult for a company to prove that their device is equivalent to another product on the market. Therefore, companies must provide their own clinical data for their product. In order to do this they need approval for a clinical study or they must obtain approval in another country and then gather post-market clinical follow-up data in order to demonstrate that a clinical study is not needed. Below is a link for the new 4th revision of MEDDEV 2.7/1 for Clinical Evaluations:

http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/en/renditions/native

Getting approval for a clinical study is not necessarily easy, because physicians do not want to study a low risk product that is very similar to other products on the market. Therefore, for low-risk products companies may find it easier to gain approval outside of Europe first and to conduct a post-market clinical follow-up study outside Europe in order to gather the clinical data needed for a clinical evaluation. Below is a link for the PMCF Guidance Document (MEDDEV 2.12/2):

http://ec.europa.eu/DocsRoom/documents/10334/attachments/1/translations/en/renditions/native

For anyone that wants more information, you might want to read my blog on the topic of clinical evaluations for Class I devices:

http://medicaldeviceacademy.com/class-1-devices-clinical-evaluation/

You can also download a new FREE webinar by Jan Dugas on the topic of clinical studies from my website:

http://medicaldeviceacademy.com/clinical-study-basics-webinar/

source: https://www.linkedin.com/groups/2070960/2070960-6161557047881068544