Beste FDA-Recht Anwälte in Reutlingen

About FDA-Recht Law in Reutlingen, Deutschland

There is no German statute called “FDA-Recht.” In Germany and the EU, regulation of drugs, medical devices, food, and dietary supplements is governed by EU rules and national laws, not by the U.S. FDA. In Reutlingen a business or individual must follow EU and German frameworks for safety, marketing, labeling, and post-market duties.

In practice, this means compliance with EU medical device rules, pharmaceutical regs, and food-safety laws implemented through German authorities such as the BfArM and BVL. U.S. FDA requirements may be relevant for cross-border trade or if you are exporting to the United States, but they do not replace EU-German obligations for products sold in Germany.

In Germany, the central authorities for medicines and medical devices are the Federal Institute for Drugs and Medical Devices (BfArM) and the Federal Office of Consumer Protection and Food Safety (BVL), aligned with EU regulations.

Source: BfArM and BVL official sites provide the framework for national implementation of EU rules on medicines, devices, and食品 safety. See the links below for authoritative sources on current German and EU requirements.

For context on practical timelines and processes, see EU regulatory summaries and German codifications such as the Arznemittelgesetz (AMG), Medizinproduktegesetz (MPG), and the LFGB for foods and supplements. AMG (Arzneimittelgesetz), MPG (Medizinproduktegesetz), LFGB (Lebensmittel- und Futtermittelgesetzbuch).

Why You May Need a Lawyer

• A Reutlingen-based company plans to bring a new drug to the EU market and must navigate EU MDR-associated processes, local approvals, and post-market reporting with BfArM.
• You operate a medical device business in Baden-Wurttemberg and must comply with the MDR or IVDR, including conformity assessment, labeling, and vigilance reporting to the EU and German authorities.
• A local food business imports or distributes dietary supplements and needs LFGB labeling, health claims review, and traceability requirements to avoid recalls or enforcement actions.
• Your company is conducting a clinical trial in Germany under the EU Clinical Trials Regulation (EU-CTR 536/2014), requiring regulatory submissions, ethics approvals, and trial monitoring in several German sites.
• You face a regulatory inquiry, product recall, or enforcement action by BfArM or BVL due to suspected non-compliance or safety concerns with a drug, device, or food product sold in Reutlingen or the Baden-Wurttemberg region.
• You plan to import or market an FDA-cleared product in the EU and need a German attorney to ensure EU- and Germany-specific regulatory alignment, labeling and language requirements, and cross-border compliance.

Local Laws Overview

The regulatory framework for FDA-Recht matters in Reutlingen combines EU-wide rules with German implementing statutes. The most relevant laws include the following, with recent or applicable dates noted where appropriate.

• Arzneimittelgesetz (AMG) - German implementation of EU medicines regulation for marketing authorizations, pharmacovigilance, and post-market surveillance. See the AMG text for the current provisions and amendments at gesetze-im-internet.de/amg.
• Medizinproduktegesetz (MPG) - German implementation of EU medical device rules, including conformity assessment and vigilance reporting. Current text available at gesetze-im-internet.de/mpg.
• Lebensmittel- und Futtermittelgesetzbuch (LFGB) - Governs labeling, safety, and claims for foods, supplements, and related products sold in Germany. See the LFGB at gesetze-im-internet.de/lfgb.

Recent EU-wide changes include the Medical Devices Regulation (MDR) 2017/745 becoming applicable in May 2021, and the In Vitro Diagnostic Regulation (IVDR) 2017/746 becoming applicable in May 2022. These updates modify conformity assessment, post-market surveillance, and labeling requirements for devices and diagnostics used in Germany.

Regulation (EU) 2017/745 on medical devices applies in EU member states since 26 May 2021.

Regulation (EU) 2017/746 on in vitro diagnostic devices applies since 26 May 2022 in the EU.

Clinical trials in Germany fall under the EU Clinical Trials Regulation (EU-CTR 536/2014), which became applicable across the EU on 31 January 2022. For official details, see the European Medicines Agency and EUR-Lex pages: EMA CTR overview, CTR 536/2014.

Frequently Asked Questions

What is FDA-Recht and how does it apply in Germany?

FDA-Recht refers to compliance issues related to FDA-regulated products in the German market. In Germany, EU and national laws govern drugs, devices, and foods, so you must align with AMG, MPG, LFGB, and EU MDR/CTR. If you export to the US, FDA considerations apply in parallel.

How do I know if my product needs BfArM approval in Reutlingen?

Most medicines require BfArM or EMA authorization for EU distribution, and devices may need conformity assessment by a Notified Body under MDR. A German attorney can map your product to the correct approval path.

When does EU MDR apply to a new device sold in Germany?

EU MDR has been applicable since 26 May 2021. Manufacturers must meet enhanced post-market surveillance, labeling, and clinical evidence requirements.

Where can I verify labeling requirements for a food supplement in Baden-Wurttemberg?

Labeling must comply with LFGB and EU food regulations, including ingredient listing, nutrition information, and health claims. Local authorities and BVL provide guidance for retailers in Baden-Wurttemberg.

Why would I need a local lawyer rather than a national firm for FDA-Recht matters?

Local lawyers understand Baden-Wurttemberg administrative practices, court processes, and nearby enforcement contacts. They can coordinate with national authorities like BfArM or BVL efficiently.

Do I need to file adverse event reports for a drug I sell in Germany?

Yes, pharmacovigilance and adverse event reporting are mandated under AMG and EU rules. A lawyer helps you implement compliant reporting systems and document retention.

Is it possible to import FDA-approved products into Germany legally?

Import is allowed if the product meets EU-German regulations for medicines or devices. Documentation, labeling, and facility compliance are typically required.

Should I consult before claiming health benefits for a supplement in Germany?

Yes. The LFGB and EU rules restrict unsubstantiated health claims for foods and supplements. A lawyer can review proposed claims for compliance.

How long does it usually take to obtain a drug authorization in Germany?

Timing varies by product type, but a new drug submission can take several months to years, depending on data sufficiency and authority review cycles.

What is the difference between AMG and MPG in practice?

AMG governs medicines including active substances and marketing authorizations, while MPG governs medical devices and their conformity processes. Both require compliance programs and vigilance reporting.

Can a small Reutlingen business defend against a mistaken recall?

Yes. You can challenge or respond to a recall with evidence and a clear corrective action plan. Legal counsel helps communicate with authorities and manage risk.

Is there a pathway to appeal a regulatory decision in Germany?

Yes. German administrative courts handle appeals and judicial review of agency decisions. A lawyer helps prepare the appeal and coordinate with authorities.

Additional Resources

• BfArM - Federal Institute for Drugs and Medical Devices - National authority for medicinal products and medical devices in Germany. https://www.bfarm.de
• BVL - Federal Office of Consumer Protection and Food Safety - Oversees food safety, labeling, and feed regulation in Germany. https://www.bvl.bund.de
• European Medicines Agency (EMA) - EU-wide regulatory overview for medicines and clinical trials. https://www.ema.europa.eu

Additional official EU resources for specific regulations include MDR/IVDR and CTR pages on EUR-Lex. EUR-Lex access

Next Steps

1. Define your regulatory issue clearly, including product type, target markets, and current compliance status in Germany and the EU.
2. Gather all relevant documents such as product specifications, labeling, safety data sheets, and any existing approvals or CE marks.
3. Search for a lawyer or law firm in Baden-Wurttemberg with formal practice in Arzneimittelrecht, Medizinprodukterecht, or Lebensmittelrecht. Contact the Rechtsanwaltskammer Karlsruhe for referrals.
4. Schedule an initial consultation to discuss scope, costs, and timelines. Prepare a concise brief and a list of questions about compliance steps.
5. Request a written engagement letter outlining fees, retainer, and expected deliverables. Confirm whether work will be billed hourly or by project.
6. Obtain a compliance plan with milestones for MDR/IVDR, AMG approvals, or CTR submissions, including expected review timelines.
7. Begin the regulatory path with your attorney, coordinating with BfArM, BVL, or other authorities as needed and tracking all communications.