Sam Attard | 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

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Three new UK Approved Bodies announced by the MHRA

31 August 202331 August 2023 by Sam Attard

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

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

We Are Recruiting

1 September 202322 August 2023 by Sam Attard

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

Meet Advena at Medica 2023

20 November 202316 August 2023 by Sam Attard

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

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

Meet Advena at Med-Tech World 2023

23 October 20231 August 2023 by Sam Attard

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

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

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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

Three new UK Approved Bodies announced by the MHRA

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

We Are Recruiting

Meet Advena at Medica 2023

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

Meet Advena at Med-Tech World 2023

Update on Guidance MDCG 2020-3 Rev.1

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