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News from the world of medical devices

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EU - form for reporting of interruption or discontinuation of supply

On December 6 the MDCG published MDCG 2024-16 and an associated Annex that contain the form for reporting according to Article 10a of MDR and IVDR and an table in case more than one device (model) is affected. The respective Q&A document has not yet been updated at this time.

Manufacturers should consider this form when integrating the requirements of Article 10a into their quality management system.

EU - New MDCG guidance documents

The MDCG published two new guidance documents in November.

MDCG 2024-14 covers the implementation of the Master UDI-DI solution for contact lenses. MDCG 2024-15 determines how clinical investigation reports and their summaries will be published in the absence of the respective EUDAMED module.

EU - Q&A document on the gradual roll-out of EUDAMED

The EU has published the third and final Q&A document on the latest changes in MDR and IVDR, addressing questions on the gradual roll-out of EUDAMED.

EU - Update of the MDCG vigilance Q&A guidance

The MDCG has updated the guidance document MDCG 2023-3 and published it in revision 1. The updated version expands the scope to cover MDR and IVDR, includes new questions and additional examples.

EU – Q&A document on reporting of interruption or discontinuation of supply of certain devices

The EU-Commission has published a Q&A document addressing the additional reporting requirements of interruption or discontinuation of supply of certain devices introduced in Article 10a qith the latest MDR and IVDR changes. The document supports manufactures in the interpretation of the requirements. A referenced “Manufacturer Information Form” that is planned for the reporting is currently not yet available.

EU – New and updated MDCG guidance documents

The MDCG has published one new and two revised guidance documents.
The new guidance MDCG 2024-13 addresses the regulatory status of ethylene oxide, especially the delineation between medical device and biocide. Guidance MDCG 2022-5 on borderline cases between medical device and medicinal product is now available in revision one, with the added case of products specifically intended for cleaning, disinfection and sterillisation of medical devices. Already in mid-October the MDCG updated guidance MDCG 2021-25 on the application of MDR requirements to “legacy deivices”. In Revision 1 the document was re-structured and substantially changed, taking into account the changes to the MDR.

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Medical device manufacturers

A fresh perspective can pave the way for amazing forces of change. We will work hand-in-hand with your team, bringing our expertise, enthusiasm and up-to-date knowledge to your business. Are you experiencing resource bottlenecks in your projects?
We can support you, for instance, in the further development of your QM system, during audits or when creating a technical documentation.

Start-ups

Have you set up your own business with a product idea? Are you on fire for your innovation - but unsure how to meet all the legal and regulatory requirements? Thanks to many years of experience in the medical device industry, we know exactly what is important now. Take advantage of our expertise surrounding development and manufacturing. So that you can concentrate fully on your core competence.

Research facilities

We support research groups in the life sciences sector, helping them to get their research results out into the world – for instance, when developing innovative materials, coatings or new diagnostic methods. When doing so, we always keep the regulatory requirements in mind, which ensures that your research results are always usable.

Our 4-point plan
for your success

Our interdisciplinary team of scientists and engineers, lead auditors and an occupational safety specialist look forward to sharing their expertise with you. Benefit from our professional services, tailor-made training opportunities, and established network of experienced specialists.

1

Consultation

regarding the development, manufacture and authorisation of the products: We show you paths and procedures that will help you reach your goal without any detours.

2

Implementation

of your projects: Our experts complement your existing resources and work together with your team to implement projects.

3

Training

for your staff: Get your teams ready for their work with tailor-made in-house seminars and workshops.

4

Sustainability

for long-term success using your quality management system: We support you with training opportunities on the latest topics, during internal audits, during supplier qualification and when continually developing your processes.

Current events
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Highlights from our seminars

Basic seminar on medical devices

This seminar covers the basics of medical devices that previously fell within the remit of EC Directives 93/42/EEC and 90/385/EEC and now fall under the remit of European Regulation (EU) 2017/745. It is intended to provide an insight into the most important areas within the legal requirements for medical devices in Europe and establish a link to practical work.

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Medical device consultant as per Section 83 of the German Medical Device Law Implementation Act (MPDG)

In accordance with the German Medical Devices Act (MPG), medical device manufacturers are obligated to ensure that medical device consultants and safety officers as per Sections 30 and 31 of the MPG have completed a sufficient level of training. This seminar is intended to provide employees in these roles with the knowledge they need to confidently work with the MPG and to explain their tasks a...

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Basic seminar on risk management – Module 1

At the heart of the legal requirements for medical devices in Europe are the fundamental safety and performance requirements (previously known as essential requirements) that must be met by all medical devices. As a basis, they require a risk management system that covers all phases of the product life cycle to be implemented by the company. The prospective identific...

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