Newsletter No 41 January 2024

Subject: MDR certification in accordance with Regulation (EU) 2017/745 on medical device

In this issue of the newsletter, we are pleased to inform you that Sengewald Klinikprodukte GmbH with its sites in Rohrdorf/Bavaria (Sengewald) and in Horb am Neckar/Baden-Württemberg (MSP Schmeiser) has managed its second stage audit according to MDR in January.

The two weeks’ audit at both sites was carried out by TÜV Süd with the aim of

• EN ISO 13485:2016
• ISO 9001:2015

• Council Directives 93/42/EEC (MDD) including the additional requirements of MDR Article 120 (3) after May 26th 2021 and IVDR Article 110 (3) after May 26th 2022:

Stage 2 certification on:
• Medical Device Regulation (EU) 2017/745 – annex XI Part A

Based on the evidence reviewed the Audit Team concludes that the company’s Quality Management System is effective and conforms to the Audit Criteria and now only one step is missing before completing the MDR journey for all our product portfolio. We are planning the completion of the last step by mid of the year.

The complexity of this regulatory stage 2 has demanded our utmost attention and commitment to ensure compliance and uphold the highest standards in our products and processes. As a result, we regret to inform you that there will be only today’s short release MDR related for this month.

Our team is working diligently to navigate through the regulatory requirements, and we look forward to sharing exciting developments with you in the near future.

The next and more detailed MDR newsletter will be issued in February We wish everyone a productive month.

Augusto Orsini
CEO STS Medical Group

Meritxell Laguna
Group Manager Regulatory Affairs
STS Medical Group