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All items used in healthcare for the diagnosis, prevention, monitoring, or treatment of a sickness or disability that accomplish their primary intended action through physical means are referred to as “medical devices.”
There is a huge variety of products available, thousands of which are used daily by both patients and healthcare professionals. Pregnancy tests, blood glucose monitors, pacemakers, hospital beds, radiotherapy equipment, surgical instruments, syringes, contact lenses, walking frames, condoms, heart valves, resuscitators, and other assistive technology devices.
Some gadgets may contain a medication that has an additional effect. A medical device of this type can be a coronary stent that releases drugs. In vitro diagnostic (IVD) medical devices are included in the scope of medical device regulation.
Any medical device that is used alone or in combination and that is intended by the manufacturer to be used in vitro to provide information on, for example, a physiological or pathological state or to monitor therapeutic measures is considered an IVD medical device.
This includes reagents, reagent products, calibrators, control materials, instruments, and apparatus. These include urinalysis test strips, specimen containers, and pregnancy test kits (such as blood collection tubes).
The foundational area of the healthcare sector is medical technologies (MED). Every significant American supplier has a presence in Germany, including GE Healthcare, Johnson & Johnson, Becton Dickinson, Abbott, Abbvie, Thermo Fisher Scientific, Stryker, Zimmer, 3M, McKesson, Cardinal Health, and Henry Schein, to mention a few. Germany is one of the biggest importers and exporters of medical devices within the EU.
The German market offers a stable political, economic, and regulatory framework and is distinguished by fair competition. Germany is in a prime position to export goods throughout the continent thanks to its strategic position in Europe.
The Germany Medical Devices market accounted for $XX Billion in 2021 and is anticipated to reach $XX Billion by 2026, registering a CAGR of XX% from 2022 to 2027.
The introduction of its medical cannabis product in Germany has been announced by Dr. Reddy’s Laboratories Ltd. and MediCane Health Inc. In addition to providing logistical and regulatory support, MediCane will deliver the medical cannabis products to Dr. Reddy’s from its EU-GMP-certified facilities in Portugal.
Dr. Reddy’s will provide access to MediCane’s medical cannabis products under its own brand in Germany as the sole distributor, supported by a trained field team that can instruct medical professionals on how to use the products and give advice on the health insurance reimbursement procedure.
In order to advance answers to the issues found in implementing the new EU Medical Devices Regulation at the European policy level, BVMed and SNITEM, Medtech organizations established a Franco-German initiative with representatives of the EU Commission (MDR).
The ultimate objective of the efforts must be to consistently provide patients with care using safe and cutting-edge medical equipment.
The CE mark, which must be secured for all products sold in Europe with a medical purpose in mind, is a rule that applies to all medical devices made in Germany. In Europe, organisations known as “notified entities” that work on behalf of the government certify medical equipment rather than governmental agencies.
Germany is home to 10 notified bodies, so manufacturers have numerous options when determining the safety of the equipment they make.
ADVOS, a German medical device startup, creates a system to streamline and enhance the care for critically ill patients receiving intensive care.
ADVOS, which is authorised for use in Europe, supports the primary detoxification organs of the liver, lungs, and kidneys. A patient in intensive care would often require individual machines for each of these organs as well as additional assistance to maintain the acid balance and detoxify the blood.
Multi-organ failure is the leading cause of death in the intensive care unit. In clinical testing, the ADVOS device was able to increase the survival rate of critically ill patients from 20% to 50%, which was previously the average.
The new ART Fixation System is now available in Europe, according to NGMedical GmbH, a medical device manufacturer solely dedicated to developing cutting-edge technology for spinal use.
The ART Fixation Method was created to give the surgeon a fixation system to easily, swiftly, and successfully perform dorsal spinal stabilizations. With a small equipment set and sterile-packed implants, ART provides a secure and straightforward instrumentation. One universal screw type is used in the lumbar fixation system’s design to efficiently address all lumbar spinal fixing needs. This is yet another important addition to NGMedical’s growing line of products.
Berlin Heart’s objective is to join the treatment continuum at an earlier stage, enable patients to avoid transplants, and possibly even enable heart recovery, using both paracorporeal and implanted ventricular assist devices that are being developed for heart failure.
The Digital Care Act and digital health solutions known as “DiGA” are being aggressively implemented by the German Health Ministry and its organization, Health Innovation Hub.
DiGA Fast Track is Germany’s route for digital health solutions to enter the statutory health system, gaining access to over 75 million Germans who are covered by the country’s mandated health insurance. The Federal Institute for Drugs and Pharmaceuticals, BfArM, a subsidiary of the German Health Ministry, is accepting online applications for DiGAs.
If certified as a medical app, DiGAs can be prescribed by any German doctor. German insurance funds will reimburse DiGA service providers.
German hospitals can speed up digitalization and maintain their competitiveness internationally thanks to the Hospital Future Act and its support. Due to a lack of focus on digitalization among German health policy makers and hospital administration for years, as well as a dearth of specialized digital solution providers, there has been a current innovation vacuum in the German hospital sector.
This makes the market particularly accessible to American digital solution providers. With the addition of the new Patient Data Protection Act-related paragraph 360 to Germany’s SGB V social code, e-medication is also on the horizon (PDSG).
The German government’s “Medical Informatics” funding programme, which is a part of the Health Research Framework Program, aims to improve data exchange between various institutions and locations in an aging society where conditions like cancer, dementia, and various cardiovascular, metabolic, and muscular ailments will become more common.
The goal is to save expenses through quicker diagnoses and treatments while assisting patients in receiving quicker, more accurate care.
The U.S. German Digital Health Forum, which was established by the U.S. Commercial Service in collaboration with a significant German digital health platform, continues to grow and provides access to cutting-edge U.S. digital health solution providers as well as opportunities for them to establish connections with German university hospitals.
Opportunities for U.S. businesses to work in Germany are provided by the German government’s funding effort for health informatics and the activities of the German states on healthcare digitization.
A procurement for the public hospitals in North Rhine-Westphalia to redesign and renovate existing facilities might serve as an illustration. U.S. businesses will have the chance to take part in consortia or work as subcontractors during a four-year period.
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