About us
Normec’s expert in regulatory compliance and certification of medical devices. Normec BuP is a trusted partner in the healthcare sector and specializes in CE marking for medical devices and the certification of quality management systems. With our extensive experience, we support manufacturers, distributors, and operators of medical devices throughout the EU and worldwide, ensuring compliance with the highest regulatory standards.
Contact us
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Nevinghoff 20, D-48147, Münster, Germany
+49 (0) 251 53 08 98 40
post-bup@normecgroup.com
Accreditations & Recognitions
Services
Explore our services and discover how we can support you. With a wide range of solutions, we help you address a variety of challenges, tailored to your organization.
Regulations & Guidelines for Medical Devices
The following PDF file contains an overview of the most important overarching documents in the field of medical devices for medical device manufacturers. We continuously review and update this list and incorporate new developments as quickly as possible. It includes European directives and regulations, their transposition into German law, as well as publications from the Notified Bodies Exchange of Experience (EK-Med), the International Medical Device Regulators Forum (IMDRF), the Medical Device Coordination Group (MDCG), and the European MEDDEV guidelines for medical devices. The list also indicates the relevance of these documents for medical device manufacturers.
We are part of the Normec Group.
Normec is a leading organisation in the TICC industry (Testing, Inspection, Certification, Compliance). Our areas of expertise range from (drinking) water quality, air quality and soil quality to fire safety, food safety, management systems, fair labour, good working conditions and social compliance. Every day, we work towards a safe, healthy and reliable working and living environment. For this and future generations.