Important Deadline for IVD Manufacturers
Manufacturers of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR) must be aware of a fast-approaching regulatory milestone. In accordance with (EU) 2024/1860, in order to benefit from the extended IVDR transition periods, manufacturers must satisfy a number of criteria, two of which will be due at the end of May. These ...
Important Dates for Manufacturers
Several critical regulatory deadlines are approaching in May 2025 that manufacturers of medical devices and in vitro diagnostic devices (IVDs) should be aware of: UDI Labelling Requirement By 26 May 2025, manufacturers of Class I (MDR) and Class B & Class C (IVDR) devices must ensure that the UDI carrier is affixed to the device ...
Current State of Play for Medical Devices (MDR & IVDR)
We understand that the regulatory landscape of the MDR and IVDR is constantly changing, and in order to keep up to date with the changes, we have provided a current state of play with regards to some of the most important changes to the MDR and IVDR. MDR Extension Firstly, we would like to remind ...
Q&A Published on Transitional Provisions for Products Without an Intended Medical Purpose Covered by Annex XVI of the MDR
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 ...
Team Notified Body Issues a Position Paper Regarding the Transfer Agreement for the Surveillance of Legacy Devices
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. ...
Flowchart Issued Relating to the Applicability of the Extension in Transitional Periods as Detailed in (EU) 2023/607.
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 ...
EU Commission Release Harmonised Manufacturer Self-Declaration Template
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. ...
Regulation (EU) 2023/607 – Meeting the Obligations of the Amended Transitional Provisions
On the face of it, this seems simple. Manufacturers can simply self-declare and the Q&A Document states this in section 7. Furthermore, it states that such a self-declaration could be based on a harmonised template. The downfall here is no such thing currently exists. Additional evidence could be provided by Notified Bodies (NB) again by ...
Q&A on the Practical Aspects Related to the Implementation of Regulation (EU) 2023/607 Amending Regulations (EU) 2017/745 and (EU) 2017/746.
The EU have swiftly issued this Q&A document after fast-tracking Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. It’s an interesting document and some will certainly find the information helpful, but in truth, this only clarifies what is ...
MDR Extension Amendment Comes into Force
The much-anticipated amendment regarding the extension of the MDR transitional periods and the removal of the sell-off dates of both MDR and IVDR has entered into force as of 20th March 2023. The amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the ...
