Close this search box.

Case: Missed mixed status devices in a system

Incorporated IVD A multi-component device is intended to be used surgically invasive, where a specific intervention can be performed via a minimally invasive technique. During this operation, a sample can be taken and stored in a container for transfer to the lab. Sampling is optional, it is not the main objective of this intervention. When … Read more

Devices that are used together, components, accessories, systems, procedure packs, and the rest…

Do standalone devices exist? Medical devices are typically used in a wider therapeutic or diagnostic context. They are often used together or sequentially with other products, often medical devices or medicinal products, and sometimes also other types of products. They may be connected or compatible, they may interface or be used simultaneously. They may use … Read more

Check your consistency, your notified body will do that for sure

Helping your notified body working efficiently We all know that notified bodies are in short supply and they should work as efficient as possible. There is something we can all do to help: prepare documentation well. It sounds obvious, but I still have to explain to companies that notified body reviewers want to see clear, … Read more

Article 16 – some loose ends in the Regulations…

Article 16 inconsistencies As you can read in another tip of the week, MDR Article 16 allows for a third party to repackage or relabel a device or to translate the instructions for use and add them to a device already placed on the market. Packaging, labelling and providing user information are typical manufacturer’s responsibilities … Read more

Article 16, where ends the responsibility of the manufacturer?

Manufacturer versus importer/distributor The MDR relates specific roles and responsibilities to manufacturers, importers and distributors. Only the manufacturer should therefore make changes to the information provided with the device and the packaging. However, sometimes the importer and/or the distributor make such changes. Article 16 of the MDR/IVDR sets out when such change puts a manufacturer … Read more

CEO’s and General Managers: selecting a PRRC is not a popularity contest

Person Responsible for Regulatory Compliance Article 15 of both MDR and IVDR require manufacturers and authorized representatives to appoint a Person Responsible for Regulatory Compliance (PRRC). MDCG Guidance 2019-7 provides guidance (be aware that this guidance is under review and we may see a new version in Q4 of 2022). Appointing the right person for … Read more