Regulation

Whether it's the European Medical Device Directive (MDD) or other international regulations. It is important for the medical device industry to keep abreast of the latest regulatory developments.

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Posts - that's to be discovered on the topic (10)

Früh Verpackungstechnik AG 1 / 1-328
Service

Accredited laboratory services

We also offer our quality standards, which we apply to our own machines and processes, to our customers in the form of services: 14 test methods are accredited in accordance with ISO/IEC 17025.

JÜKE Systemtechnik GmbH 1 / 1-628
Service

Regulatory Affairs

Benefit from the extensive and long-standing experience of our experts: We accompany the entire process, from consulting to approval requirements, standard-compliant development and production through to the certification of medical devices.

MedtecLIVE
Interview

Interview on the PFAS ban: "Companies and associations should participate in the consultation"

PFAS are often indispensable for medical technology due to their biocompatibility and durability. The planned ban poses problems for the industry. We took the situation as an opportunity to ask Frauke Averbeck from the Federal Institute for Occupational Safety and Health.

MedtecLIVE
Trendreport

MDR/IVDR: The bodyguards for medical devices

The MDR and IVDR have been the subject of debate since they were adopted in 2017. The regulation for medical devices and the regulation for in-vitro diagnostics in Europe aims to improve the safety and quality of medical devices for patients.

ALLTEC Angewandte Laserlicht Technologie GmbH 1 / 1-408
Best practice

The laser marking solution for medical technology

The UDI guideline introduced by the FDA (Food and Drug Administration) requires medical products to be clearly labeled. This ensures traceability. Correct implementation is a concern for medical device manufacturers and raises a number of questions.

MedtecLIVE
Market & Industry

PFAS ban: Economics ministers call for return to risk-based approach

The industry association Spectaris welcomes the decision of the Conference of Economics Ministers not to abandon a risk-based approach to the planned PFAS ban and to consider a classification as "substances of low concern" for fluoropolymers, for example.

MedtecLIVE
Market & Industry

Amendments to the Medical Devices Regulation adopted

The European Parliament voted positively on the draft amendment to the Medical Device Regulation (MDR). Since the Council already gave its approval at the end of January, the amendment has now been de facto adopted. Manufacturers are thus given more time to transfer existing products to the MDR.

MedtecLIVE
Market & Industry

Federal Minister of Health presents digitalisation strategy: "Modern medicine needs digital help"

By the end of 2025, 80 per cent of the users of an electronic patient record (ePA) who are undergoing medication treatment are to have a digital medication overview. And by the end of 2026, 300 research projects with health data are to be realised by the new Research Data Centre Health.

seleon GmbH
Market & Industry

Common Specifications addressing Annex XVI Devices

In a significant development for the Medical Device Regulation (MDR) landscape, the adoption of the Common Specifications within the Commission Implementing Regulations 2022/2346 and 2022/2347 on 1st of December 2022 marks a pivotal milestone.

seleon GmbH
Service

Consulting Services of seleon GmbH

We are not “THE CONSULTANTS”, but engineers, clinical and regulatory experts as well as quality managers whose profound expertise is based on a multitude of international development, manufacturing and approval projects of medical devices.