Services Archives - Klaas consulting

Related Services

by Klaas | Apr 30, 2021 | Services

In addition to our Sales and Marketing assistance we can assist you in all services around a medical device. These services will be mainly executed through our partners and associates located in the country being considered.

Support in Regulatory Compliances
CE Consulting
Acting as your European Authorized Representative
FDA Consulting
Judicially Advices for medicinal products and medical devices
Headhunting
Training & Coaching

Please contact us to forward your request.

Marketing Consulting – Medical Devices

by Klaas | Apr 30, 2021 | Services

A carefully directed sales and marketing plan is critical to your business success. Our support orientates this in each phase.

Finding the optimal marketing strategy for your marketing objectives
Selecting the best strategic sales channels for your medical devices and your company
Specifying marketing tools and implementing the appropriate communication mediums

Market and Marketing Research

by Klaas | Apr 30, 2021 | Services

To know the obstacles means to know your strategy – knowing the market barriers is the key to succeeding in market entry and development.

We undertake any research necessary for entry onto the market and include advice from our market experts about potential pitfalls.

Research of market structure, market segmentation
Determination of market sizes and potentials (based on secondary market analysis figures)
Investigation of market situation and tendency
Competitor analysis
Analysis of product and market prices

Reimbursement Consulting

by Klaas | Apr 30, 2021 | Services

If qualifying for reimbursement is critical to your success, we can help you determine the path to reimbursement approval in the European markets.

Whether your products focus on the hospital, institutional or homecare segment, our reimbursement experts can find the answers to your questions.

Country-by-country understanding of reimbursement requirements
Product reimbursement analysis
Preparation and submission of dossiers
Monitoring of changes in laws and requirements

Distribution Consultancy Services – Medical Devices

by Klaas | Apr 30, 2021 | Services

Our distribution consultancy services focus on companies poised to sell their products in the European market.Your intention is either to expand your existing European distributor network of medical distributors or to enter a new European market for the first time.

Or — you are looking for somebody in Europe who can manage your already established medical distributors.For all of these we offer a total package:

Defining the best sales strategy and determining your individually matched distribution channels
Finding medical distributors in every European country through our research expertise, our experienced contacts and our network partners
Assisting you during the negotiation process until finalization of a contract
Managing your already established medical distributors on your behalf
Developing a Sales Organization

Meet us at Arab Health (29. January-01. February 2024) – ask for an appointment!

Latest Insights

(Jan 24) TÜV Süd BABT Unlimited is an approved UK Aproved Body (UKAB) for Part III of the UK Medical Devices Regulations 2002 for Active Implantable Medical Devices (AIMD). Manufacturers can now obtain both UKCA and CE certification from TÜV Süd at the same time.
(Jan 24) Expansion of the AOP catalogue by the GKV-Spitzenverband
(Jan 24) Eudamed: the mandatory use of the UDI/Medical Devices Registration and Certificates/Notified Bodies modules has been postponed from Q1 2026 to Q2 2029
(Jan 24) 43 Notified Bodies in 18 countries are now accredited. Currently there are 10 each in Italy and Germany, 3 in the Netherlands; in addition, two each in Finland, Poland and Czech Republic and one each in Belgium, Denmark, Hungary, Lithuania, Norway, France, Slovakia, Slovenia, Spain, Sweden,Turkey, Ireland, Croatia and Cyprus. Nando database
(Jan 24) New guidelines and documents from the Medical Device Coordination Group (MDCG) from December 2023: 1) MDCG 2023-5 Guidance on qualification and classification of Annex XVI Products A guide for manufacturers and notified bodies and MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products A guide for manufacturers and notified bodies, 2) MDCG 2021-6 Rev. 1 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation, 3) MDCG 2021-27 – Rev.1, 4) MDCG 2023-7
(Aug 23) Swissdamed (Swiss Database on Medical): ACT module, available from the beginning of 2024 for the registration of companies; registration of products via UDI module, available from summer 2024.
(Aug 23) TÜV Süd, Germany also UK Approved Body (UKAB) for medical devices. Current list of UKAB according to the UK Government's Medicines and Healthcare products Regulatory Agency.
(May 23) The Medical Device Regulation Group (MDCG) published guidance on 12 May 2023 on the significant changes to the transitional provision under Article 120 of the MDR
(May 23) Great Britain decides to extend the deadline for CE marking of medical devices according to MDR. From July 2025, the new legal framework is to apply
(March 23) Transition periods for the approval of medical devices in Europe now legally extended.
- May 2026: Custom-made medical devices (Class III).
- December 2027: Higher-risk medical devices (non-exempt Class IIb implants and Class III medical devices)
- December 2028: Low-risk medical devices (Class IIa, Ir, Im, Is).
(March 23) Current information from BfArM on the German Medical Devices Information Database System (DMDIS), "Clinical Investigations/Performance Evaluations" module for all user groups (as of Jan. 30, 2023)
(Jan 23) Manufacturers of digital care applications (DiPA) can now apply directly to the BfArM for inclusion of their application in the DiPA directory via a digital application portal
(Jan 23) Since 1.1.2023, condoms have been available free of charge in pharmacies in France for people between 18 and 25 years of age. Since 1 year also contraceptives, e.g. IUDs and the birth control pill.
(Dec 22) According to. MHRA (Medicines & Healthcare products Regulatory Agency), the United Kingdom will continue to recognise the CE mark for medical devices until 30 June 2024. Previously, 30.6.2023 was planned.
(Dec 22) According to the Roland Berger MedTech@Hospital study, about two-thirds of German hospitals expect to close the 2022 financial year in the red. More than half also plan to invest less in medical technology.
(Nov 22) According to the Roland Berger study "Global MedTech-How to succeed in uncertain times", the medical technology industry is struggling with high energy costs, rising inflation and supply chain problems. Solutions are offered by digitalisation, more benefit-based billing models and the shift towards personalised medicine.
(Nov 22) Facts&Figures 2022 from MedTech Europe, the European trade association for the medical technology industry
(Nov 22) New MDCG document on requirements for Notified Bodies - in the context of the MDR as well as IVDR
(Nov 22) Swissmedic refers to a leaflet on the obligations for authorised representatives, importers and distributors
(June 22) studies published by the German Society for Biomedical Engineering in the VDE (VDE DGBMT)
1. "Use of sensors in combination with implants and application systems".
2. "Approval of medical implants according to the European Medical Device Regulation (MDR)".
(June 22) the EU Commission published a document in June 22 for the IVDR: "Harmonised administrative practices and alternative technical solutions until EUDAMED is fully operational".
(June 22) The Interest Group for Medical Devices in Germany (IG-NB) has published 2 guides on the topics of
1. artificial intelligence (AI)
2. cybersecurity
Medical device manufacturers can apply to the Joint Federal Committee (G-BA) for the NUB and receive advice on the procedure. Rules of Procedure of the G-BA.
(April 22) Distinction between medical devices and medicinal products: Guidance document MDCG 2022 of the Medical Devices Coordination Group
GTAI has created a special page on sanctions and the consequences of the war in Ukraine.
Internet platform for medical needs in Ukraine by the German initiative Medical Bridge.eu
European industry association for digital assistive technology DATEurope founded in early 2021. DAT includes aids for communication, for the blind and visually impaired, for environmental control, assistive call systems, software tools and robotics.
New web portal for the list of medical aids according to §139 SGB V of the GKV-Spitzenverband: for reference and online application
Overview of all assessments of new examination and treatment methods (NUB) by the G-BA
the MHRA in the UK has published a guidance document for manufacturers and distributors of medical devices
BfArM included the first “apps on prescription” in the new directory for digital health applications (DiGA) in early October 2020
EU-implementation regulation for the reprocessing of disposable products, valid from 26 May 2021
FDA increases medical device registration fees from October 2020
The European Commission published the new “Clinical evaluation assessment report template” of the Medical Devices Coordination Group (MDCG) on 17 July 2020
In-vitro-diagsnostics must be re-evaluated according to the new IVDR by 26 May 2022.
The new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 has entered into force. It must be implemented for products... with higher risk by May 2025, ...with lower risk class C by May 2026, ...with lower risk classes B and A by May 2027