What is the Medical Device Law Implementation Act?

Medical Device Law Implementation Act Definition

The Medical Device Law Implementation Act (MPDG) is the latest set of regulations that applies to companies that manufacture, distribute or market medical devices in Germany. MPDG replaces the previous Medical Devices Act (MPG) and is intended to supplement MDR 2017/745. The MPDG regulation outlines processes that are specific to Germany including clinical trials, product labeling, and medical device classification.


What is the Safe Medical Devices Act (SMDA)?

The Safe Medical Devices Act of 1990 requires medical device user facilities (i.e., hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility) to notify any suspected death, serious illness, or injury to the U.S. Food and Drug Administration (FDA) and manufacturer. It is designed to protect the public by ensuring that medical devices are not unsafe for their intended use.

*Source: https://www.congress.gov

What are MEDDEV documents?

The MEDDEV Guidance Documents are created on behalf of the European Commission by several working groups to help stakeholders in implementing medical device directives. The MEDDEVs encourage manufacturers and notified bodies involved in conformity assessment procedures to have a common approach.

*Source: https://akrnconsulting.com

What does medical device regulatory affairs do?

Regulatory affairs professionals in the medical device industry are responsible for leading premarket strategy, drafting regulatory submissions, and ensuring post-market compliance.

*Source: https://www.northeastern.edu

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