Regulatory consulting for medical device manufacturers, from initial classification through market surveillance: In the European Union, the Medical Device Regulation (MDR) requires a robust classification for each product, evidence of compliance with essential safety and performance requirements, complete technical documentation, a clinical evaluation, and an effective quality management system before CE marking can be granted.
For in vitro diagnostic medical devices, the corresponding requirements of the IVDR apply; for the U.S. market, the FDA’s regulations apply; and each additional target market entails its own documentation requirements.
We have been guiding manufacturers through the entire regulatory process since 1993, from the strategic classification of a new product to ongoing support in the market.
For the European market, the MDR provides the framework; for in vitro diagnostic medical devices, the closely related requirements of the IVDR apply. For the U.S. market, we guide clients through FDA requirements, including the 510(k) process, and for other regions, through the respective national approval pathways. WQS supports quality and risk management, software and digital products, as well as all post-market obligations. The following medical device consulting services can be utilized individually or as part of a comprehensive support package.
WQS considers medical device consulting not merely as working through individual checklists, but as collaborative support throughout the entire product lifecycle. We translate the complex requirements of the MDR, IVDR, ISO 13485, and international frameworks into concrete, actionable steps tailored to your product and the size of your company.
Experience in regulatory affairs and quality management for medical devices.
successfully completed certification and CE marking projects.
Market access for the EU, as well as the U.S., India, and other target markets.
During the initial consultation, we classify your product, identify the applicable regulation, and show you the specific next step.
We start with an objective assessment of your product and your goals, review the regulatory status and existing documentation, and determine the specific next steps based on this analysis. We then work with you to prepare the necessary documentation and remain your point of contact even after market access is achieved.
We clarify the product, target markets, and current regulatory status during a free initial consultation.
We review the classification, existing documentation, and any gaps, and identify specific actions needed.
We prepare and finalize the required documentation.
We remain your point of contact for market surveillance, product changes, and upcoming audits.
When it comes to regulatory issues, experience matters. WQS has been guiding medical device and IVD manufacturers through approval processes in the European Union and internationally since 1993. During this time, we have guided products across a wide range of risk classes through the conformity assessment process, from simple Class I products to complex, software- and AI-based medical devices.
The CE mark (Conformité Européenne) confirms that a medical device meets the requirements of the EU Medical Device Regulation (MDR) (EU) 2017/745. It confirms that the product is safe, performs as intended, and may be sold in the EU.
Yes. CE marking is required by law.
Every medical device must undergo a conformity assessment procedure before being placed on the market.
The duration depends on the product’s risk class, the status of the existing documentation, and the workload of the Notified Body. For Class IIa products with complete technical documentation, a realistic timeframe of 12 to 18 months should be planned. For Class III products or in cases of incomplete documentation, the process is extended accordingly.
For every medical device, complete technical documentation in accordance with MDR Annexes II and III is required. It includes: product description and specifications, evidence of compliance with the essential safety and performance requirements (ESPRs according to MDR Annex I) with product-specific test reports, a risk management dossier according to EN ISO 14971, a clinical evaluation according to MDR Article 61, post-market surveillance documentation, instructions for use and labeling, as well as UDI documentation.
For Classes IIa, IIb, and III, the quality management system in accordance with MDR Annex IX or XI is also required.
For Class I devices, the involvement of a Notified Body is not required; however, the technical documentation must be provided in full.
EUDAMED (European Database on Medical Devices) is the European database for medical devices. Manufacturers must register, obtain a Single Registration Number (SRN), and enter their products, including UDI data. Mandatory use of all EUDAMED modules takes effect as of May 2026. EUDAMED registration is a prerequisite for placing products on the market in compliance with regulations.
Yes. Every medical device manufacturer that does not have an established place of business in the European Economic Area is required under MDR Article 11 to appoint an EU authorized representative (EU Representative). The EU Representative is legally responsible to the market surveillance authorities, must be registered in EUDAMED, and serves as the point of contact for all regulatory inquiries in the EU. This role can be outsourced to a specialized company such as WQS. Without a designated EU Representative, the product may not be placed on the market in the EU.
CE marking is required for any medical device that is placed on the market, made available on the market, or put into service in the European Union (EU). WQS advises you on carrying out the conformity assessment procedure and affixing the CE mark.
WQS offers medical device manufacturers consulting on CE marking and guides them through the entire conformity assessment process in accordance with the EU Medical Device Regulation (MDR).
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
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This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.
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