2026 EU MDR/IVDR: Importer Requirements & FAQs

Find out the importer''s requirements under the MDR/IVDR. Plus, what are the manufacturer''s obligations to/from the importer and how are direct

Cable Regulations in the European Union: An Overview

Cables imported or manufactured in the European Union are subject to various regulations and directives. The specific regulations and

OEM Standards Insights for Better Compliance

OEM standards refer to the technical, quality, regulatory, and performance benchmarks that original equipment manufacturers must meet to ensure

MDR-Practical Guide Implementation of Regulation EU 2017/745

MDR-Practical Guide Implementation of Regulation EU 2017/745 (MDR) Requirements for Suppliers of Medical Devices and Materials used to Manufacture Medical Devices All manufacturers* of medical

Placing UKCA or CE marked products on the market in Great Britain

What you need to do to comply with regulations which govern manufactured products placed on the market in Great Britain.

How to apply for Original Equipment Manufacturer (OEM) Authorization

How to apply for Original Equipment Manufacturer (OEM) Authorization Kindly we are bidding to supply some network equipment and we are are required to present Original Equipment

Union format for manufacturer s authorisation

The Competent Authority is responsible for the appropriate linking of the authorisation with the manufacturer''s application (Article 42(3) of Directive 2001/83/EC as amended and Article 90(3) of

Reflection Paper on Good Manufacturing Practice and Marketing

Article 46 relates to the obligations that are placed upon the holder of the manufacturing authorisation, and sub-point (f) requires the finished product manufacturer “to use only active substances, which

LUMER Cable Management Stand (Adjustable Height

The Lumer Cable Management Stands provide a very effective solution to tidying away loose cabling on site. They are fully portable, highly

Union format for manufacturer''s authorization

The authorisation referred to in paragraph 40(1) of Directive 2001/83/EC as amended and Article 88(1) of Regulation (EU) 2019/6, shall also be required for imports coming from third countries into a Member

Manufacturing and Import Authorisation (MIA) and European Market

ProPharma''s Manufacturing and Import Authorisation (MIA) Licenses help accelerate product launch and market access in the EU and UK.

Concept paper on Good Manufacturing Practice and Marketing

The current EU Guide to GMP refers in several places to Marketing Authorisation Holder (MAH) companies and their responsibilities in relation to GMP ensuring that the manufacturing authorisation

CE marking – obtaining the certificate, EU requirements

CE marking Many products require CE marking before they can be sold in the EU. With this marking, the manufacturer indicates that a product meets the

BfArM

Here you will find answers to frequently asked questions about manufacturing authorisation/import authorisation.

Heads of Medicines Agencies: Medicines Approval system

EU Directives are implemented through national legislation. There are four different routes to obtaining a Marketing Authorisation (MA) which result in the issue of three different types of MA; a National only

Standards and Certification

Meka Pro''s products are supported by robust manufacturer''s declarations and certifications, which are critical for ensuring the quality and safety of our cable

The Star

The Star brings you breaking news, developing stories, politics, entertainment, lifestyle, sports and much more from Kenya and around the world, throughout

Product compliance

What are product requirements? How to identify product rules and requirements? Find out what the EU obligations are for manufacturers,

Eudralex Volume 10 Union basic format for manufacturing

Eudralex Volume 10 Union basic format for manufacturing authorisation / Union basic format for manufacturers / importers

Comprehensive Guide on European Authorised

Authorised Representatives are imperative for any non-EU businesses wishing to place their products on the EU marketplace. With the new

Medical devices

Medical devices are products or equipment intended for a medical purpose. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in a number of regulatory

Guidelines on applications for authorisation to manufacture and import

Storage of own manufactured medicines at one of the company''s sites that has not been part of the manufacture of the medicine, requires a wholesale distribution authorisation at this site.

Interpretation of the Union format for Manufacturer/Importer Authorisation

Appropriate documentation should be provided by the manufacturer/importer to the relevant Competent Authority as evidence of the name of the Authorisation Holder legally registered address.

The Cableway Installations Regulations 2018

We will advise the operator/promoter on whether we consider a proposed change is significant enough to require a new authorisation. This approach is similar to the HSE practice for lifts, whose...

Manufacturing Authorisation of ATMPs

Manufacturing authorisation: is an authorisation that shall be hold by any legal entity wishing to manufacture a medicinal product in the EU. It is issued by the national competent

HDMI Licensing Administrator, Inc.

HDMI.org is the licensing agent to administer licensing of HDMI Specification, promote HDMI technology and provide education on the benefits of HDMI interface..