Market access

The approval of medical devices and in vitro diagnostics can vary depending on the country of destination. While there are efforts to align these processes or create similar requirements for products, differences still exist at present. In addition, some directives and regulations have been revised or replaced by new ones in recent years. Here we give you an overview of the topic.

Germany

The necessary requirements for access to the German market.

Europe

The requirements according to the regulations of the EU Commission.

USA

National regulations for the US market

MDSAP

The programme for simplified access to certain participant markets.

Germany

Germany as a market for medical devices is largely oriented towards EU regulations. However, there is also the Medical Devices Implementation Act and other national regulations, some of which go beyond the EU requirements. The specific regulations, directives, etc. that are relevant for Germany are briefly listed below.

Europe

With the MDR and the IVDR, Europe has uniform regulations as a requirement for access to the markets, although individual countries can impose additional requirements in their national laws. In general, the requirements of the MDR/IVDR and the superseded MDD/IVDD are similar. However, the MDR/IVDR requires more detailed and precise technical documentation.

USA

As in other countries, national regulations take priority when it comes to market access for medical devices in the USA. While the US is a member of the MDSAP, specific regulations such as 'Title 21 CFR 820', '510(k)' and '513(g)' still apply.

MDSAP

The MDSAP is a facilitated auditing and initial approval programme for the markets of participating countries. However, it should be noted that national regulations take priority. Participating countries include the USA, Canada, Japan, Brazil, and Australia, while Singapore, South Korea and Argentina are affiliate members.

Name	Purpose	Lifetime	Type	Provider
CookieConsent	Saves your consent to using cookies.	1 year	HTML	Website
fe_typo_user	Assigns your browser to a session on the server.	session	HTTP	Website

Name	Purpose	Lifetime	Type	Provider
_ga	Used to distinguish users.	2 years	HTML	Google
_gat	Used to throttle request rate.	1 day	HTML	Google
_gid	Used to distinguish users.	1 day	HTML	Google
_ga_--container-id--	Persists session state.	2 years	HTML	Google
_gac_--property-id--	Contains campaign related information for the user. If you have linked your Google Analytics and Google Ads accounts, Google Ads website conversion tags will read this cookie unless you opt-out.	3 months	HTML	Google