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EU - Q&A document on changed IVDR transition timelines published

After the publication of  Regulation (EU) 2024/1860 in the official journal, the commission has now provided a Q&A document that explains the new timelines and provisions with respect to the changes in the IVDR transition period. Additional Q&A documents for the newly introduced obligation to inform in case of interruption or discontinuation of supply for manufacturers and the gradual roll-out of EUDAMED will follow.

EU - Updates to MDCG guidance documents

The MDCG updated two of its guidance documents:

MDCG 2021-5 provides information on standardisation for medical devices and was updated to revision 1. MDCG 2020-16 explains the classification rules for in-vitro diagnostics and is now available in revision 3.

EU - regulation changing MDR and IVDR published in EU journal

After passing the parliament and councils the regulation to change MDR and IVDR has now been published in the officiel EU journal as Regulation (EU) 2024/1860. The regulation is immediately in force and applicable with the exception of the reporting obligations to manufacturers in case of shortages of certain medical devices that will become applicable on January 10 2025.

EU - MDCG Guidance on Clinical Evaluation for Orphan Medical Devices

The MDCG published MDCG 2024-10 that includes guidelines for the clinical evaluation of orphan devices. The guideline defines orphan devices as indicated for diseases or conditions that present in not more than 12.000 individuals per year within the EU. In addition there have to be either insufficient treatment options or an expected improved benefit by the device under evaluation.

EU - Update of the SCHEER guidelines for risk-benefit-assessment of phthalates

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published an update of the guidelines on the benefit-risk assessment of phthalates with carcinogenic, mutagenic, reproduction toxic or endocrine disruptive properties. The guideline can also be used for other substances with comparable properties, the presence of which above a certain threshold requires a justification according to MDR Annex I.

EU - Council approves changes to MDR and IVDR

After the EU Parliament now the Council has adopted a regulation changing the MDR and IVDR (press release). The only missing step now is the publication in the Official Journal. The changes introduced include further extending the transition period for certain IVDs, enabling a gradual roll-out of EUDAMED, and requiring manufacturers to flag up potential shortages of critical medical devices and IVDs.

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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.

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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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