The EU Commission has updated the current state of MDR/IVDR applications with the notified bodies. The results have been documented in a .pdf power point which is split up into 3 sections: About the study and survey, Survey results for medical devices, Survey results for in vitro diagnostic medical devices. From the results, one can … Read more
It’s no secret that software has become an integral part of many medical devices on the EU market. It is estimated that a quarter of medical devices either incorporate a software or could be considered to be a medical device software in their own right. In many cases, the MDSW can only achieve its intended … Read more
A revision to the MDR has been published by the EU in which they intended to streamline the UDI requirements for certain products, starting with contact lenses. This new revision sees an easing of the UDI requirements for contact lenses and hence a reduction in the associated administrative burdens by allowing for manufacturers to assign … Read more
An update to the Manual on Borderline and Classifications under the MDR and IVDR has been published. The last update, version 2, was issued in December 2022, and since then has been updated to include the following devices: Root canal irrigation solutions, Temperature sensors embedded in orthopaedic devices for compliance tracking, System intended to produce … Read more
On June 21, 2023, the Official Journal of the European Union published the Implementing Regulation (EU) 2023/1194 amending the transitional provisions laid down in Implementing Regulation (EU) 2022/2346 for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (MDR). This document has been adopted to align the transitional provisions … Read more
Surveillance by the notified bodies is a condition that needs to be satisfied in order to make the manufacturer eligible for the extension in the transitional periods. Usually, the surveillance activities would be undertaken by the notified body that issued the CE certificate under the previous directives, as stated in Article 120 (3) the MDR. … Read more
Regulation (EU) 2023/607, that has been adopted in March 2023, amends the transitional provisions for certain medical devices covered by the Medical Device Regulation (EU) 2017/745 (MDR). The transitional provisions were introduced in order avert any risk critical medical devices shortages in the EU market and to help with the limited capacity of the notified … Read more
As many manufacturers currently know, there are many conditions that you must satisfy in order to be eligible for the extension in transitional periods. Although these conditions are stated on the EU 2023/607 document, reading through these conditions, and subsequently determining the applicability could get confusing, and at times hard to follow. In light of … Read more
On the 18th July, the EU Commission published its updated Q&A document on the practical aspects related to the implementation of Regulation (EU) 2023/607 as regards the transitional provision for certain medical devices and in vitro diagnostic medical devices. We had mentioned this in our recent newsletter and it has been posted on our website. … Read more
The initial document of the Q&A, released in late March, provided guidance for the amendment to the extension in transitional provisions. This document was well received by many entities within the regulatory space. There has been an update to the Q&A document that has been released in mid-July. The document conveniently includes a change history … Read more
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