WQS is your experienced partner for CE Certification of Medical Devices, international market approvals, and regulatory services across the field of medical technology. With decades of experience, we support U.S.-based companies in successfully entering the European market.
We assist in the Development, Implementation, and Maintenance of Quality Management Systems (QMS) for Manufacturers, Service Providers, and Distributors in Production, Services, Trade of all Industries in the medical device sector – in compliance with international standards such as:
Complying with legal and normative requirements in connection with Medical Devices, In-Vitro Diagnostics and their CE Mark for Manufacturers, Operators, Reprocessors and Distributors of Medical Devices.
The requirements for placing Medical Devices on the Market, both non-sterile and sterile, and In Vitro Diagnostics are taken into account. The following laws, ordinances and regulations apply to every Manufacturer of Medical Devices and/or In Vitro Diagnostics:
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 Marking, 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 this purpose, 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.
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 certification process depends on the Device’s Risk Class.
You must prepare a complete Medical Device Master File, including a Risk Management File (per ISO 14971), evidence of conformity with the General Safety and Performance Requirements (Annex I MDR), and product-specific documentation for EUDAMED and DMIDS Registration.
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.
WQS provides you with detailed information on your subject.
You can also explore our FAQ page and other resources for further insight
– or simply contact us for direct support.
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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