Among the companies we guide are ProCore, Seegnal, VVT Medical, and NanoPass, which developed innovative technology for intradermal injection—a method that recently received FDA approval as part of the monkeypox vaccine campaign.

Since the MedTech (medical technology) field involves unique regulations, we have received requests from members of the EXITEAM community to clarify various terms from this sector.

Without further ado, here is a brief glossary to help you better understand the world of MedTech regulation:

CE

The CE marking (from French—Conformité Européenne) is a mandatory marking for products marketed in the European Economic Area.

This marking certifies that the product meets the standards and regulatory requirements of European institutions, including health requirements.

EMA

A European Union agency responsible for the approval and supervision of drugs, pharmaceuticals, and medical procedures. This is the European equivalent of the American FDA (see entry).

This body, based in Amsterdam, the Netherlands, is responsible for approving drugs and other medical procedures for both human and veterinary use.

The name EMA is an acronym for The European Medicines Agency.

The European agency was established in 1995 through funding from two sources: the European Union on one hand, and the pharmaceutical industry on the other. The joint establishment of the agency was intended, among other things, to improve cooperation between the various organizations operating in different European countries, together with pharmaceutical companies.

Among other things, the establishment of the agency was intended to prevent cases where European countries refused to approve drugs that compete with products from local manufacturers, in order to prevent competition.

FDA

The U.S. Food and Drug Administration. This is the body responsible for oversight and regulation of food products, drugs, cosmetics, medical devices, tobacco products, and various other products.

The FDA is considered worldwide to be a reliable and thorough institution, and decisions by the Food and Drug Administration can influence the approval of various products in different countries.

In the 1950s, the FDA refused to approve the use of thalidomide, a drug widely used in Europe and also here in Israel.

Over time, it was discovered that this drug increases the risk of birth defects. The FDA’s insistence on not approving the drug due to lack of preliminary testing strengthened the FDA’s standing in the United States itself and throughout the world.

Since this case, the FDA has been considered worldwide as an authoritative body regarding the approval of various drugs.

To obtain FDA approval, one must comply with the standardization system (see Standard) and submit for examination according to regulated parameters, and only then can distribution in the U.S. be permitted.

Not every medical aspect requires FDA approval. For example, Seegnal, while addressing the pharmaceutical field, is a software company, so there is no requirement to obtain FDA approval before distribution in the U.S.

MDR

MDR is an acronym for Medical Device Regulation, a new European Union regulation that came into effect approximately a year and a half ago.

This is a new regulation for medical equipment, designed to unify the various requirements for medical equipment in the Union. Until now, there were countries in the European Union that required different criteria for approval of medical equipment—and the MDR aims to end this phenomenon and align all EU member states.

MDSAP

MDSAP is an acronym for Medical Device Single Audit Program. This is a set of requirements for various organizations and institutions worldwide that are required to examine and approve the quality management of medical device manufacturers.

This program was born out of a need and desire to create a uniform list of requirements suitable for regulatory institutions worldwide engaged in the health and medical field.

The MDSAP began in 2011 through collaboration between Canada, Australia, Brazil, Japan, and the United States.

For MedTech companies interested in marketing their products in various markets worldwide, this is truly welcome news.

Instead of dealing with different requirements from different regulatory bodies, which requires considerable effort and investment—the MDSAP created a unified system that meets the regulatory requirements of many countries.

AMAR

AMAR is a Hebrew acronym for “Medical Devices and Equipment Division.” This is a division of the Ministry of Health, responsible for registering medical devices, issuing import permits, and more.

The division began in 1993, under the name “AMAR Unit.” Beyond its oversight and control functions, the division also assists in exporting medical devices and equipment to foreign markets by issuing official documents for various bodies and institutions.

Clinical Trial / Human Trial

In the approval process for new drugs, various institutions (such as the FDA and MDR, see entries) require conducting a clinical trial / human trial.

This trial is designed to examine, on one hand, the efficacy of the drug before it is approved for use, and the risks or side effects that may result from using the drug, procedure, or innovative treatment.

These are extremely expensive trials, as they must meet very stringent requirements in terms of research methodology and the ethical issues such trials raise.

Clinical trials in medical treatments for humans have been conducted throughout history. The Book of Daniel describes a kind of clinical trial, when Daniel asked the king of Babylon to conduct an experiment in which one group of people would eat the local food, and another group would eat only kosher food for ten days, to see if there is a difference in the effect of kosher or non-kosher food on humans.

According to the account in Daniel, incidentally, the group that ate kosher was healthier than the control group.

Despite the various trials conducted throughout history, it is generally accepted to regard a trial conducted in 1749 in the treatment of scurvy as the first modern clinical study.

Standard

To ensure that systems meet clear standards, norms and uniform requirements have been established, aimed at ensuring a quality and functional product. The standard specifies for each product the requirements that apply to the product, process, or service, in order to ensure suitability for their intended purpose. There are local standards and international standards such as CE or FDA.

We hope this brief glossary will help you navigate the MedTech world a bit better.