MDR | Advena Ltd

Concept of MDR Medical Device Regulation.

Q&A Published on Transitional Provisions for Products Without an Intended Medical Purpose Covered by Annex XVI of the MDR

29 September 202328 September 2023 by Sam Attard

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

Team Notified Body Issues a Position Paper Regarding the Transfer Agreement for the Surveillance of Legacy Devices

31 August 202331 August 2023 by Sam Attard

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

Team Notified Body Issues a Position Paper Regarding the New MDR Transition Timelines & Notified Body Capacity

31 August 202331 August 2023 by Sam Attard

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

Flowchart Issued Relating to the Applicability of the Extension in Transitional Periods as Detailed in (EU) 2023/607.

31 August 202324 August 2023 by Sam Attard

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

EU Commission Release Harmonised Manufacturer Self-Declaration Template

31 August 202311 August 2023 by Ant Kirby

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

Update of the Q&A Document on the Extension of the MDR Transitional Period

31 August 20234 August 2023 by Sam Attard

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

Update on Guidance MDCG 2020-3 Rev.1

31 August 202320 June 2023 by Sam Attard

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

Regulation (EU) 2023/607 – Meeting the Obligations of the Amended Transitional Provisions

2 October 202411 May 2023 by Ant Kirby

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

Q&A on the Practical Aspects Related to the Implementation of Regulation (EU) 2023/607 Amending Regulations (EU) 2017/745 and (EU) 2017/746.

31 August 202330 March 2023 by Ant Kirby

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 … Read more

MDR Extension Amendment Comes into Force

31 August 202322 March 2023 by Ant Kirby

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 … Read more

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Q&A Published on Transitional Provisions for Products Without an Intended Medical Purpose Covered by Annex XVI of the MDR

Team Notified Body Issues a Position Paper Regarding the Transfer Agreement for the Surveillance of Legacy Devices

Team Notified Body Issues a Position Paper Regarding the New MDR Transition Timelines & Notified Body Capacity

Flowchart Issued Relating to the Applicability of the Extension in Transitional Periods as Detailed in (EU) 2023/607.

EU Commission Release Harmonised Manufacturer Self-Declaration Template

Update of the Q&A Document on the Extension of the MDR Transitional Period

Update on Guidance MDCG 2020-3 Rev.1

Regulation (EU) 2023/607 – Meeting the Obligations of the Amended Transitional Provisions

Q&A on the Practical Aspects Related to the Implementation of Regulation (EU) 2023/607 Amending Regulations (EU) 2017/745 and (EU) 2017/746.

MDR Extension Amendment Comes into Force

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