Wim Vandenberghe

Wim is an EU regulatory partner who focuses on the life sciences sector.

Wim helps pharmaceutical, medical device, cosmetics, and food companies navigate the regulatory process in Europe throughout the life cycle of their products – from planning and development to approval and marketing, and through to enforcement and ongoing compliance. His work has been recognised by The Legal 500 in its 2024 list of notable EU Regulatory: Pharma, Medical Devices, and Biotech practices.

This includes advising clients on a broad range of regulatory issues, such as regulatory pathways, product classification, marketing authorisations, CE marking, clinical trials, product, GxP/QMS requirements, internal compliance processes and procedures, advertising and promotion, HCP/HCO interactions (including fraud and abuse), market access, adverse event reporting and recalls, and digital health. He also assists clients with regulatory due diligence evaluations regarding the compliance status of acquisition targets in the life sciences sector, as well as post-acquisition integration.

He frequently works with Reed Smith’s U.S. FDA team to provide equivalent advice on EU regulations to the firm’s clients in international matters.

As a natural corollary of his regulatory practice, Wim has developed substantial experience in drafting and negotiating industry-specific agreements, including contract manufacturing, development and commercialisation, supply, quality and pharmacovigilance, distribution, and other related agreements (e.g., CTA, CRO, MSA, MTA, and API).

Wim has represented clients before EU and national regulatory agencies in investigations and enforcement matters. This work also includes carrying out internal audits, developing corporate compliance programmes, and assisting with supply chain and product liability claims.

In addition to his life sciences practice, Wim also advises more generally on EU market access matters in multiple industries, such as consumer products, industrial machinery, e-commerce, technology, and manufacturing, and he is a core member of the firm’s Retail and Consumer Goods Group. This work includes counselling on product standards (safety, health, and environment), regulatory compliance approvals (including CE marking, packaging, and labelling), cross-sectoral requirements (e.g., materials and waste management, sustainability, and carbon neutrality), and internal market issues. He advises on the legal, practical, and procedural aspects of EU law-making, engaging with EU institutions to anticipate, understand, and influence policy and the legislative and regulatory developments that impact clients’ businesses.

Wim has been quoted by The Wall Street Journal, The Economist, Politico, PaRR, Food Quality and Safety, New Europe Online, Bloomberg Businessweek, and Dow Jones Newswires.

Experience

Representative matters

Advised a consortium of medical device manufacturers on whether guidance issued by the European Commission – that would “up classify” software as a medical device as a higher risk medical device – was compatible with the EU Medical Device Regulation and general EU treaty law.

Advised a diabetes device manufacturer with overall compliance of its glucose monitoring system under medical device regulations, as well as other issues such as:

justified collection and use of patient data under medical device regulations versus data protection;
its collaboration agreement with a pharmaceutical company in terms of quality/safety/post market surveillance requirements as well as patient data sharing;
allegations of non-compliance with vigilance reporting duties;
misuse of its system by a third party for a nutrition coaching program; and
data sharing collaboration and informed consent requirements.

Reviewed marketing materials of a US medical device company following its obtaining of a CE mark to commercialise products in Europe.

Medical devices

Advised a diabetes device manufacturer with overall compliance of its glucose monitoring system under medical device regulations, as well as other issues such as:

justified collection and use of patient data under medical device regulations versus data protection;
its collaboration agreement with a pharmaceutical company in terms of quality/safety/post market surveillance requirements as well as patient data sharing;
allegations of non-compliance with vigilance reporting duties;
misuse of its system by a third party for a nutrition coaching program; and
data sharing collaboration and informed consent requirements.

Reviewed marketing materials of a US medical device company following its obtaining of a CE mark to commercialise products in Europe.

Advised a real-time data collection and epidemiological monitoring tool with compliance under medical device regulations.

Advised a US based medical device manufacturer in relation to obtaining market access and CE marking in Europe.

Reviewed existing contractual arrangements of a medical device manufacturer (authorized representative, distributor, HCP, and clinical trial) to guarantee contractual compliance with the provisions of the EU medical device regulations.

Conducted an in-depth regulatory due diligence relating to a private investment firm’s acquisition of a medical device company with major manufacturing and commercial activities in Europe.

Advised a global manufacturing company on regulatory issues relating to medical devices following its acquisition in Europe of a medical device manufacturer. Issues concerned: compliance with the new EU medical device regulation and FDA rules and review of distribution agreements.

Review template distribution contract of a global manufacturer relating to the sale and distribution of medical devices in Europe to comply with medical device regulations.

Advised a U.S. medical devices and health care company on digital health issues under the EU MDR, such as data sharing collaboration and informed consent requirements.

Advised a U.S. industrial company on its acquisition of a German medical device company with respect to EU MDR compliance and post-acquisition regulatory issues.

Counselled medical device companies on all aspects of the new EU MDR, including classification rules, CE marking, borderline determinations, software/health apps, supply chain duties and roles, contract modifications, data transparency, track and traceability, clinical investigations and evidence, post-market surveillance and vigilance.

Advised medical device companies on the assessment, under the EU MDD and MDR, of software and mobile applications as well as the distinction with health apps and medical devices the resulting legal implications.

Provided advice to a leading supplier of high-technology cardiology, endovascular, and oncology products on compliance issues under the new EU MDR.

Provided compliance advice to a leading supplier of cardio-oncology devices with respect to the new EU IVDR.

Assisted a medical device manufacturer with respect to recall measures imposed by the French Agency for the Safety of Health Products and the European Commission surrounding a defective radiotherapy device.

Advised a U.S. medtech company in off-label promotion and product defect investigation by European health agencies.

Represented a global medtech company in its response to EU health agencies’ inspection and warning letters.

Reviewed possible EU compliance issues in the context of a possible sale of a U.S. company active in the business of renting test and measurement equipment such as oscilloscopes.

Pharmaceutical and biotechnology

Advised a cloud-based patient and HCP cardiac monitoring platform regarding clinical data requirements and how this fits within its overall data strategy.

Advised a technology company which develops data-driven insights pertaining to neurological diseases for various health care research organizations with guidance on international clinical trials standards.

Advised a global manufacturing company with a government tender in the Netherlands for the delivery of equipment for the production of radioisotopes.

Reviewed international distribution agreements for the subsidiary of a global manufacturing company relating to the sale of equipment to be used in the medical and biopharmaceutical industries.

Assisted a pharmaceutical company with regulatory due diligence (FDA and EU) in connection with its bid in a competitive process to acquire a global contract research organisation (CRO).

Advised a life sciences company on the strategic, commercial and regulatory aspects of mislabeled raw materials sold to vitamin manufacturer and potential recall and related exposure in the EU.

Assisted a biotech company with the negotiations of its clinical trial agreements in Europe.

Counselled a U.S. biotech company on market access issues in relation to the launch of its EMA approved drug.

Advised pharmaceutical companies on applications for the centralised and national approval of medicines.

Provided advice to pharmaceutical companies on compliance with applicable marketing laws and codes of best practice, including anti-bribery and sunshine rules.

Assisted a multinational pharmaceutical company with the formation of a blockchain consortium.

Provided advice to a global influenza vaccine company on a European-wide contract for the manufacturing and supply of vaccines.

Counselled a global generics medicine company on the EU data protection, disclosure and access mechanisms.

Reviewed pharmaceutical companies’ pricing, market strategy, and commercial practices to ensure compliance under EU life sciences and competition laws.

Conducted regulatory due diligence for a U.S. radiopharmaceuticals manufacturer for its IPO.

Co-advised (along with a global consulting firm) a leading European pharma company on its pricing and market access, including value-based contracts.

Counselled a U.S. pharma company on EU requirements for clinical trials, as well as possible funds or tax reductions linked to SME status.

Advised a pharmaceutical manufacturer on changes to EU rules governing (pre)clinical safety testing.

Advised a pharmaceutical manufacturer on the qualification of production/toxic waste and by-products under EU waste law.

Successfully defended a manufacturer of animal health products (pharmaceuticals, vaccines, parasiticides, diagnostics, capital equipment, supplies, and specialty products) in court proceedings against claims made by a distributor for commercial negligence and regulatory non-compliance.

Reviewed the different application of EU good manufacturing practice guidelines by selected Member States for a global pharmaceutical manufacturer.

Counselled a leading biologic company on regulatory aspects of biosimilars.

Health care, cosmetics, and food

Assisted a U.S.-based health tracking platform – that contributes real-world data to research projects – in exploring the feasibility from a regulatory perspective of expanding into select other markets. We provided regulatory analysis and counseling around whether the client's platform would be considered software as a medical device in the other jurisdictions, and whether research taking place over the platform would be regulated as a clinical trial.

Provided regulatory support to a U.S. digital health company interested in pursuing an EU CE mark and a UKCA mark for its artificial intelligence offering. We assisted the client with a contract to engage a physician for input on the protocol for a UK clinical validation study, and advised on consultancy fee-for-service agreements with health care providers. We also assisted the client with a clinical trial agreement with a London university hospital.

Advised a California based apparel company on the applicability of the EU cosmetics regulation when selling beauty products in Europe.

Assisted a food and agri-business company in a settlement with the European Commission on an awarded EU grant and allegations of misuse of the grant.

Advised a multinational provider of a comprehensive range of wine closures on false marketing claims and unfair commercial practices made by competitors in relation to carbon footprint and sustainability, and their validity under EU product standards.

Represented a global provider of health care services (diagnostic, clinical laboratory, cancer treatment, and renal care centers) in its litigation against a hospital for alleged breach of applicable EU regulations.

Advised an Asian market entrant on EU regulatory requirements for cosmetics and body care products.

Provided advice to a France-based cosmetics company on health claims (paraben free; no animal cruelty).

Counselled a diabetes dietary supplement company on health claims and ingredient review.

Assisted a U.S. company with the marketing of a food supplement in Europe (counselling on regulatory requirements, labelling, and health claims, among other items).

Advised a dairy company on GMO-free labelling.

Counselled a global food ingredients company on the impact of EU food regulations on customs classification.

Advised a chocolate manufacturer on labelling obligations, particularly regarding allergens.

Advised a U.S. leader in the provision of outpatient diagnostic imaging services on its acquisition of a majority stake in a UK-based teleradiology network, which involved assessing required licensure changes and registration with the UK Quality Care Commission and translating certain key health care regulatory duties and overall compliance requirements into reps and warranties in the purchase agreement.

EU market access and Product Compliance

Advised a foreign based steel producer on implementation and compliance of the EU carbon border tax adjustment mechanisms.

Advised a multinational technology company on various issues of the EU single digital market, notably in relation to the transposition in France of the EU copyright Directive.

Advised an EU trade federation in relation to the compatibility under EU law of an interpretation by the German Federal Minister for the Environment of EU Regulation 2019/1021 on persistent organic pollutants.

Advised a market-leading supplier of AI-driven broadband and Wi-Fi optimization software in relation to the unlawful use of its technology by a telecom incumbent by developing regulatory arguments.

Advised a global e-commerce company on various internal market issues such as:

Product compliance and liability issues under EU market surveillance regulation and General Product Safety Regulation;
Compatibility under EU law of the proposed French reparability index and prepared submission to the European Commission
Compatibility of the French medialaw reforms under EU law, in particular the EU copyright directive.

Advised a global supplier of printing technology and inks with compliance under the EU REACH and CLP regulations.

Advised a global chemicals company on compliance with the EU Packaging and Packaging Waste Regulation and impact on its raw materials supply agreements.

Counselled a European based car manufacturer on EU rules for connected and automated cars and how to avoid being qualified as a telecom operator or service provider.

Advised a leading manufacturer of high-performance fiber optic sensor systems for guidance, navigation, and stabilization applications, regarding antenna spectrum compliance requirements under the Radio Equipment Directive (RED).

Advised a U.S. manufacturer of evaluation boards against claims made by its European distributor that the former did not comply with specific SHE legislation (RoHS Recast Directive, R&TTE and Low Voltage Directives).

Advised a semiconductor company regarding new EU conflict minerals rules which have an impact on its raw materials sourcing and supply chain liabilities.

Represented a global sport goods manufacturer in cases of non-compliance of clothes with EU chemical regulations before UK, German, and Luxembourg authorities as well as the European Commission.

Advised a U.S. video game accessories suppliers regarding age restriction notice on product packaging for action figures (EU toy safety).

Advised a U.S. guitar manufacturer on the applicable international and EU rules on the use of rare wood.

Counselled a U.S. video game accessories supplier regarding age restriction notice on product packaging for action figures (EU toy safety).

Represented an agro-chemical company before the Dutch Food and Consumer Product Safety Authority against the planned disclosure of pesticides sales data.

Counselled a manufacturer of wooden floors with compliance under the EU construction product regulations, in particular mandatory user information.

Counselled a U.S. pesticides manufacturer regarding EU standards for product labelling and packaging and developing a pan-European strategy regarding parallel import.

Advised an Asian carmaker on a range of EU regulatory issues (car emission measurements, vehicle safety rules, conflict minerals).

Conducted a review for a global logistics company of its EU waste law obligations with respect to a system of reverse logistics for electronic consumer goods.

Advised a global automotive parts supplier on the EU end-of-life vehicle directive.

Advised a leading insulation manufacturer on the EU SHE rules for glass wool.

Advised an EU trade association on the recast of the EU Persistent organic pollutants (POPs) regulation.