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
The MHRA has designated three new UK approved bodies, almost doubling it’s capacity for the certification of medical devices. There are now a total of seven UK approved bodies in the UK. These approved bodies play an important role in the medical device industry by helping manufacturers to get their device on the market and … 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
As Advena Ltd in Malta continues to grow, we are now looking to recruit an experienced Business Administrator to join our team of regulatory specialists on a full-time basis. The successful candidate will work alongside our existing team of regulatory specialists, primarily on the review and preparation of various types of documentation for submission with the Maltese … Read more
We are pleased to announce that we will be exhibiting at this years edition of MEDICA. The exhibition will be held on the 13th and 16th of November 2023 in Dusseldorf Germany. If you are interested in one of our services, or you are an existing client who would just like to meet the Advena … 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
We are pleased to announce that we will be exhibiting at this years edition of Med-Tech World. The exhibition will be held on the 19th and 20th of October 2023 at the Mediterranean Conference Centre in Valletta. If you are interested in one of our services, or you are an existing client who would just … Read more
The conditions that are set out in Article 120 (3) of the MDR include, among others, that legacy devices must continue to comply with the AIMDD/MDD, as applicable, and that there are no significant changes in the design or intended purpose of the device. The latter criteria could be considered as quite vague and could … Read more
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 … Read more
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