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This guide explains how laws and regulations that people commonly call "FDA law" interact with Swedish and EU regulatory systems for food, drugs, medical devices and related products when you are located in Solna, Sweden. The term "FDA" refers to the United States Food and Drug Administration - a U.S. regulator that controls products sold in the U.S. market. In Sweden and the EU most regulatory authority lies with national agencies and EU-level rules. For pharmaceuticals and medical devices the Swedish Medical Products Agency - Läkemedelsverket - and EU Medical Device Regulation (MDR) play the primary roles. For foods the Swedish Food Agency - Livsmedelsverket - and related EU food law apply. If your product is intended for the U.S. market, you also must meet applicable FDA requirements, so businesses in Solna often need to manage dual compliance - Swedish/EU and U.S. rules - and the legal advice needed reflects that complexity.
Regulatory matters affecting pharmaceuticals, medical devices, biologics, food, dietary supplements and related products can be complex and carry significant legal and commercial risks. You may need a lawyer when you face any of the following common situations:
- Preparing to export a product from Sweden to the U.S. and needing FDA registrations, premarket submissions and exporter responsibilities.
- Determining whether your product is a drug, medical device, food, cosmetic or combination product under Swedish, EU and U.S. rules.
- Preparing or responding to regulatory inspections, FDA foreign inspections, warning letters or inspection reports.
- Handling adverse event reports, pharmacovigilance obligations or device vigilance across multiple jurisdictions.
- Managing recalls, market withdrawals or product safety communications in Sweden, the EU or the U.S.
- Drafting or negotiating manufacturing, distribution, clinical trial or licensing agreements with U.S. or EU partners.
- Designing clinical trials that must comply with EU clinical trial rules, Swedish ethics requirements and potential FDA expectations for U.S. submissions.
- Addressing customs detention, import alerts, or enforcement by Swedish authorities or U.S. Customs and Border Protection for goods destined for the U.S.
- Ensuring data protection and cross-border transfer compliance, particularly when clinical or adverse event data must be shared with U.S. partners or authorities.
- Responding to criminal investigations or enforcement actions that may arise from alleged regulatory breaches.
Key local and regional legal frameworks you need to know when working with regulated products in Solna include the following.
- Swedish Medical Products Agency - Läkemedelsverket: The national regulator for medicines and certain medical devices. Responsible for marketing authorizations, national safety reporting and inspections of sites operating in Sweden.
- Swedish Food Agency - Livsmedelsverket: Responsible for food safety, labeling, traceability and enforcement for foods and certain supplements placed on the Swedish market.
- EU Regulations: For pharmaceuticals and many medical devices the EU regulatory framework applies across Sweden. Key EU rules include the Clinical Trials Regulation, pharmacovigilance rules, the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), plus EU food law.
- CE Marking and Conformity Assessment: For most medical devices sold in the EU a CE mark is required following conformity assessment by a notified body when applicable. CE marking and EU technical documentation differ from U.S. premarket pathways such as 510(k) or PMA.
- Good Manufacturing Practice - GMP and Good Distribution Practice - GDP: Manufacturers and distributors in Sweden must follow EU GMP and GDP for medicines. U.S. cGMP obligations will apply if exporting to the U.S.
- Data Protection - GDPR: Personal data handling - especially patient data in clinical trials or adverse event reports - must comply with the EU General Data Protection Regulation. Transfers of personal data to the U.S. require careful legal measures.
- Safety Oversight and Vigilance: Sweden requires serious adverse event reporting and post-market surveillance under EU rules. Reporting to U.S. agencies is separate when products enter the U.S. market.
- Customs and Import Rules: Swedish Customs - Tullverket - enforces import requirements. Exports to the U.S. may provoke FDA and U.S. Customs oversight, including facility registration or detention of goods.
- Criminal and Administrative Sanctions: Significant breaches of Swedish or EU safety rules can result in fines, product seizures, injunctions and, in serious cases, criminal charges against responsible individuals or companies.
The FDA has authority over products sold in the U.S., not over domestic Swedish commerce. However, if a company in Solna exports products to the U.S. the FDA can regulate those exports and inspect foreign manufacturing facilities that supply the U.S. market. Noncompliance with FDA requirements can lead to U.S. enforcement actions, import refusals or reputational harm.
No - selling in Sweden and the EU is governed by EU and Swedish rules. Medicines require an EU or national marketing authorization. Medical devices need CE marking under MDR/IVDR and may need conformity assessment by a notified body. FDA approvals are only needed if you intend to market the product in the U.S.
Dual compliance means meeting both EU/Swedish requirements and U.S. FDA requirements when you plan to sell in both markets. Requirements can differ substantially - for example device classification, clinical evidence expectations and labeling rules - so a coordinated regulatory strategy is essential to avoid duplicative studies, delays or conflicting technical documentation.
Yes, the FDA conducts foreign inspections of facilities that manufacture products for the U.S. market. If your site supplies the U.S., it should prepare for possible FDA inspection and ensure compliance with relevant U.S. quality system regulations in addition to EU GMP, where applicable.
You must follow national and EU reporting obligations for events occurring in Sweden. If the product is also marketed in the U.S., you generally must also report relevant events to the FDA according to U.S. reporting rules. Coordinated pharmacovigilance policies and data-transfer processes are needed to meet both regimes while respecting GDPR.
Trials conducted in Sweden can support FDA submissions, but they must be conducted to standards acceptable to the FDA - such as Good Clinical Practice - and documentation must meet FDA expectations. Early engagement with both Swedish authorities and U.S. regulators or regulatory counsel helps align trial design and data collection for dual use.
If a Swedish or EU authority enforces a seizure or recall you should immediately notify legal counsel and your quality and regulatory teams, preserve records, cooperate with investigators, and assess the root cause and corrective actions. If the product is also in the U.S. market, assess whether parallel or additional U.S. reporting or recall steps are needed.
Often you need both. A Swedish lawyer with regulatory experience can advise on Swedish and EU requirements, local procedures and interactions with Swedish agencies. A U.S. regulatory lawyer is helpful for FDA-specific matters, U.S. submissions and U.S. enforcement risks. Many companies engage cross-border counsel or firms with both capabilities.
Timelines vary by product and pathway. National or EU marketing authorizations for medicines can take many months to years depending on submission type. Medical device CE conformity depends on device classification and notified body capacity and can take several months to over a year. FDA premarket review times also vary - 510(k) reviews are often measured in months while PMA approvals can take a year or more. Planning and regulatory strategy significantly affect timelines.
Costs depend on regulatory pathway, studies required, notified body or FDA fees, and legal and consulting support. Even early-stage regulatory strategy and product classification advice is valuable and cost-effective. Budget for legal advice when developing your regulatory plan, before clinical trials, before first shipments to the U.S., and when preparing for inspections or responding to enforcement.
Helpful Swedish and international bodies and organizations to consult or research include:
- Swedish Medical Products Agency - Läkemedelsverket - for medicines and some devices and clinical trial applications in Sweden.
- Swedish Food Agency - Livsmedelsverket - for food safety, labeling and related enforcement in Sweden.
- European Medicines Agency - EMA - for centralized marketing authorizations and EU-level guidance on medicines.
- European Commission - for official EU legislative texts and guidance on MDR, IVDR and food law.
- Swedish Customs - Tullverket - for import-export and customs procedures.
- Local business and industry associations focused on life sciences and medtech in the Stockholm and Solna area for practical local insights.
- Data protection authorities and guidance on GDPR for handling personal data, particularly the Swedish Data Protection Authority when in-country advice is needed.
- U.S. Food and Drug Administration - for U.S. regulatory requirements if exporting to the U.S. and for information on foreign inspections and import/export rules.
If you need legal assistance in the area of FDA law while based in Solna, consider the following practical steps:
- Clarify your goal - Are you selling in Sweden, the EU, the U.S., or multiple markets? Identifying target markets determines which rules apply.
- Determine product classification - Engage regulatory counsel early to determine whether your product is a medicine, medical device, food, cosmetic or a combination product under each jurisdiction.
- Conduct a regulatory gap analysis - Compare Swedish/EU requirements with U.S. FDA requirements to identify gaps in testing, documentation, quality systems and labeling.
- Retain experienced counsel - Choose a lawyer or law firm with practical experience in both Swedish/EU regulation and U.S. FDA matters, or coordinate a team of local and U.S. counsel.
- Prepare quality systems and documentation - Implement or update GMP, quality system regulations, technical documentation and pharmacovigilance procedures to meet both regimes if needed.
- Plan for data protection and transfers - Ensure GDPR compliance and put appropriate legal safeguards in place for transfers of personal data to the U.S.
- Engage early with regulators - Consider pre-submission meetings with Swedish authorities, EU bodies or the FDA when planning pivotal trials or major regulatory submissions.
- Prepare for inspections - Develop an inspection readiness plan and train staff for both Swedish/EU inspections and potential FDA foreign inspections.
- Keep communications documented - Maintain clear records of regulatory interactions, changes to product specifications and corrective actions in the event of audits or enforcement.
If you are unsure where to start, arrange an initial consultation with a lawyer who understands cross-border regulatory issues so you can develop a practical, step-by-step compliance and market entry plan tailored to your product and business objectives.
