The CE marking signifies market authorization for the European Economic Area following the completion of a proper conformity assessment procedure. Without CE marking, your device cannot be sold anywhere in the European Economic Area.
WQS has been supporting medical device manufacturers in this process since 1993, from classification and technical documentation through to successful certification with the CE marking.
The CE marking (Conformité Européenne) confirms that a medical device meets the requirements of the Medical Devices Regulation (MDR) (EU) 2017/745. This is not a voluntary certification, but a mandatory requirement for market entry throughout the European Economic Area.
Any product that falls under the definition of a medical device per MDR Article 2 requires CE marking before it enters the EU market. This applies to US-based manufacturers in the same way as EU-based ones. The key difference: US manufacturers without an EU establishment must additionally designate an EU Authorized Representative under MDR Article 11.
For in vitro diagnostics, the applicable regulation is IVDR 2017/746 with separate risk classes, different conformity procedures, and its own set of transitional deadlines.
Class I (non-sterile, without measuring function):
Self-certification by the manufacturer. No Notified Body required. Technical documentation and DoC are mandatory.
Classes Is / Im / Ir, IIa, IIb, III:
Involvement of a Notified Body is mandatory. The body reviews the technical documentation and quality management system.
The procedure is product-specific. There is no uniform process, but there are mandatory components that apply to all manufacturers:
The device is categorized into Class I, Is, Im, Ir, IIa, IIb, or III, which determines the subsequent steps.
QMS certification according to MDR Annex IX or XI, based on ISO 13485, is mandatory for Classes IIa, IIb, and III.
For Class I, a QMS is not legally required but is de facto expected.
The technical documentation is the core of the conformity assessment procedure. It is mandatory for every risk class and comprises the complete product file, including, among other things, GSPR evidence, the risk management file, instructions for use, and labeling.
The clinical evaluation must reflect the specific product and serves as evidence of safety and performance.
For Class III and certain Class IIb products: clinical investigation or proof of equivalence with complete clinical evidence.
For Class I: clinical literature review.
For all Class I, I, I, IIa, IIb, and III products, the involvement of a Notified Body is required by law.
The Notified Body reviews and evaluates the technical documentation and the quality management system.
The manufacturer issues the EU Declaration of Conformity (DoC) and declares conformity with the MDR (EU) 2017/745 or IVDR (EU) 2017/746 for IVDs.
The CE mark may only be affixed once the DoC has been issued.
The product may be placed on the market in the EU.
After placing the product on the market, market surveillance in the form of Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSUR), and PMCF activities is mandatory.
We guide manufacturers, operators, reprocessors, and distributors of medical devices through conformity assessment procedures and assist in meeting legal and regulatory requirements related to Medical Devices, In-Vitro Diagnostics and their CE Mark.
Specifically, we cover the following areas:
Technical documentation according to MDR Annexes II & III
Preparation and review of technical documentation.
Clinical evaluation according to MDR Art. 61 / MEDDEV 2.7/1
Product-specific and dependent on the risk class.
Quality management system consulting and ISO 13485
Establishment, implementation, and maintenance of a quality management system in accordance with ISO 13485, MDR Annex IX / XI, and 21 CFR Part 820 (QMSR).
Person Responsible for Regulatory Compliance (PRRC)
WQS performs PRRC functions in accordance with MDR Art. 15.
EU Authorized Representative for Non-EU Manufacturers
WQS assumes the EU Authorized Representative function in accordance with MDR Art. 11 for manufacturers without an EU establishment.
The following laws, regulations, and directives apply to all manufacturers of medical devices and/or in vitro diagnostic medical devices:
Also especially German Laws:
A conformity assessment procedure in accordance with MDR is required for the authorisation of Medical Devices in the higher Risk Classes (Is, Im, Ir, IIa, IIb, III). This includes certification by a Notified Body, which will assess both the Technical Documentation and your Quality Management System.
While certification according to EN ISO 13485 is not legally required for CE Certification, it provides a globally recognized framework and is often expected by European Notified Bodies and international partners and is strongly recommended. Many manufacturers benefit from aligning their Quality Systems with ISO 13485, even if it is not mandatory for EU Market Approval.
For each product a Medical Device Master File (DEVICE MASTER FILE) must be created for each product. Manufacturers and the products must be registered with the European database on medical devices (EUDAMED) and with the German Medical Devices Information and Database System (DMIDS). A risk management file according to the requirements and the fulfillment of the essential safety of EN ISO 14971 and performance requirements (MDR, Annex I) are part of the basic procedure for every Medical Device (including Class I Medical Devices).
The extent to which further “Harmonized” Standards need to be considered can be found in the list of “Harmonized Standards” for the 2017/745 legislation, which is always up-to-date on the EU server.
In Europe, Medical Device Manufacturers (Distributors) must register a Person responsible for regulatory compliance (PRRC for short) in the European Database EUDAMED. For small and medium-sized companies, this role can be outsourced.
WQS offers external PRRC services, ensuring your company fulfills this core MDR requirement without the need for internal staffing.
In Germany and Austria, individuals involved in the sale or promotion of Medical Devices are required to meet specific qualifications. This includes representatives acting as a Medical Device Consultant (“Medizinprodukteberater”).
We offer tailored training programs for your representatives to comply with the national requirements. Learn more about this on our Training as a Medical Device Consultant Page.
WQS provides you with detailed information on your subject.
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CE Certification confirms that a Medical Device complies with all applicable EU regulations and standards, including the MDR (Regulation (EU) 2017/745). It is mandatory for legally placing a Medical Device on the European Market.
Yes, all Medical Devices intended for the EU Market must carry the CE Mark. The complexity of the CE Certification process depends on the Device’s Risk Class.
Every medical device requires complete Technical Documentation under MDR Annex II and III. This includes: product description and specifications, GSPR evidence per MDR Annex I with product-specific test reports, Risk Management File per EN ISO 14971, clinical evaluation per MDR Article 61, Post-Market Surveillance documentation, instructions for use, labeling, and UDI documentation. For Class IIa, IIb, and III devices, a certified Quality Management System under MDR Annex IX or XI is additionally required.
EUDAMED (European Database on Medical Devices) is the EU’s central medical device database. Manufacturers must register, obtain a Single Registration Number (SRN), and enter their products including UDI data. Mandatory use of all EUDAMED modules is required from May 2026. EUDAMED registration is a prerequisite for placing devices on the EU market. US manufacturers can register directly or through their EU Authorized Representative. Without an SRN, a device cannot legally enter the EU market.
Yes. Any manufacturer of medical devices without a legal establishment in the European Economic Area is required under MDR Article 11 to designate an EU Authorized Representative. The EU Representative is legally responsible to EU market surveillance authorities, must be registered in EUDAMED, and serves as the regulatory contact for all EU inquiries. Without a designated EU Authorized Representative, a product cannot be placed on the EU market.
The PRRC ensures compliance with MDR requirements within your organization. This role is mandatory for manufacturers and authorized representatives in the EU. Small and medium-sized enterprises may outsource this function to qualified external partners like WQS.
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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