Many manufacturers ask themselves whether a clinical evaluation or clinical trial is necessary for their medical devices. The MDR requirements are quite extensive and specific. Various products previously categorized as equivalent under the MDD now belong to a different risk class and existing clinical data are often no longer accepted by notified bodies. The MDR […]
A custom-made device in MedTech is a product prescribed to a patient by an authorized person, such as a physician. This product, by prescription, is manufactured exclusively for the respective person. Mass products with adaptions adjusted to fit the user’s needs are not considered as custom-made devices. Custom-made devices were already part of the Medical […]
What requirements must a product fulfill before it can ultimately be sold in the EU? This question is answered in the second chapter of the Medical Device Regulation (MDR). It includes information on placing products on the market, commissioning, and the role of authorized representatives. The responsibility for this lies with manufacturers, importers, and distributors. […]
Read More… from MDR – Market Entry Consideration for MedTech Products
Medical devices play a crucial role in modern healthcare. Their regulation is essential to ensure safety and efficacy. In recent years, regulatory changes in this area had a significant impact on industry and patients. In particular, regulatory requirements and changes in and around the Medical Device Regulation (MDR) are compelling stakeholders to stay on top […]
Read More… from MedTech News 2022 – The Most Important Developments
To make it easier to classify medical devices, they are differentiated into various categories. As in the Medical Device Directive (MDD), they are divided into three classes for this purpose in the Medical Device Regulation (MDR). Thus, how a product is evaluated to reach the market also differs, as there are significantly different requirements for […]
A Notified Body is a government-supervised organization designated by a member state of the European Union to test the suitability of various products before they are placed on the market. The European Commission also maintains a database of Notified Bodies called Nando (New Approach Notified and Designated Organisations). In medical technology, they are also responsible […]
At first glance, the general differences between the In Vitro Diagnostic Directive (IVDD) and the In Vitro Diagnostic Regulation (IVDR) are not particularly significant. Regulations of the IVDD continue to exist, so to speak, but they are supplemented by additional regulations, resulting in the IVDR. For example, the obligations of economic operators, i.e., manufacturers, authorized […]
Although it still seems far away, the date of the EUDAMED deadline is getting closer and closer. However, like on Christmas, you are caught off guard by how sudden the deadline comes around the corner. Good preparation is essential to face the deadline calmly. After all, the Medical Device Regulation (MDR) and especially the new […]
Due to the Medical Device Regulation (MDR), digitalization of the medical technology industry is taking place. EUDAMED plays a instrumental role in this. Among other things, it intends to ensure the tracking of medical devices. However, it also entails a host of new tasks and obligations. Obligations will have to be taken on by a […]
The EUDAMED Actor Roles are part of the Actor Registration Module. It is the first of the six modules to be made available to the public. Each person or actor must register here before using EUDAMED. The European Union defines an actor as: A natural or legal person (organization) with a specific role that must […]