Your Medical Device Consulting Group …we safely navigate you through the troubled MDR sea …
The new Medical Devices Regulation (MDR)
On April 5., 2017, the EU Parliament adopted the new Medical Devices Regulation (MDR). The scheme entered into force on May 25., 2017. The Federal Association of Medical Technology Companies in Germany (BVMed) immediately called for a german „national support program for MedTech SMEs“.
Due to lower personnel capacities and funding opportunities, small SMEs could be particularly hit hard by the demanding new clinical requirements as well as the comprehensive documentation and reporting obligations.
Under the new rules, medtech companies will have to:
In total, the industry can expect a significantly more costly path to compliance in the world’ s second- biggest medtech market. The costs associated with compliance may force some companies to take drastic steps, such us offloading product lines or even putting themselves up for sale.
The aftermath of the shake-up will be a stronger, more accountable medtech industry that may look substantially different from today’s.
Many medtech companies have begun to look at how they should address compliance, and realized that the extent of the changes requires a company-wide approach. These companies have grasped that the EU MDR represents not just a compliance challenge, but an opportunity to add value to the business at the time.
Our network services
The three-year transition period is tight. Industry has highlighted for priority the following areas:
We – as a consulting network – will support our clients in this transition by:
You will have to prepare for a new certification in 2019. For the products already CE marked, updates on clinical safety and post-market surveillance for instance will be needed.
Consulting Services & Experts
Please select one out of the four categories to identify your potential network partner.
- Clinical Trials
- Clinical Evaluations (MEDDEV 2.7.1)
- Toxicology Assessments
- Biocompatibility Assessments
- DIN EN ISO 14155
- SAE Management
- PMCF Studies
- Medical Device Law (Medizin Produkte Recht)
- European Medical Device Law
- Corporate Law
- Due Diligence Questions
- Finance & Strategy
- Commercial & Administration
- Regulatory Affairs
- Quality Management Systems
- DIN EN ISO 13485
- Life Cycle Risk Management
- Usability Assesments
- DIN EN ISO 62366
- DIN EN ISO 14971
- Cyber Security Risk Management
- Cybersecurity (CS) Training for medical device manufacturers / Conformity Assessment Body Services
Christoph R. Manegold
Initiator and network administration (RA, F&E Management, Innovation Management, Technical Due Diligence)
Dr. Jens Waldmann
Design transfer and technical documentation
Volker G. Sauerbaum
Finance, Commercial and Administration
Regulatory Affairs (MDD/MDR)
Medical Device Law, Corporate Law, M&A
Project and Quality management (ISO 13485), Technical documentation
Prof. Dr. Paul Borm
Toxicology and Nanoparticle Research
Dr. Stephan Joeken
Clinical studies and literature-based clinical evaluations
Dr. Gerhard Pohlmann
Clinic, Biocompatibility & Inhaler
Cybersecurity (CS) Training for medical device manufacturers / Conformity Assessment Body Services
Areas of Expertise
Nanoconsult is a scientific consultancy firm providing solutions and strategic approaches to complex toxicological or regulatory problems. We are recognized for our integrity, professionalism and ability to cross sectors and build bridges. Our company value is commitment to client service
With high quality know-how and network. Competence area’s:
- Drugs & Devices
- Business support
Nanoconsult is in close cooperation with the business unit:
Translational Biomedical Engineering
of the Fraunhofer ITEM (Institute for Toxicology and Experimental Medicine)
Support of medical device projects. Advice on the implementation and development of quality management systems, preparation of CE documentation and support in approval procedures, as well as all regulatory matters.
The business unit Translational Biomedical Engineering offers many years of experience in the development of medical devices – specifically neuro-implants and medical aerosolizers – including testing and testing scenarios, safety and risk assessment.
AC Aircontrols (Consulting desk)
International R&D service provider, producer and supplier of technical innovations for the medical devices industry.
Consulting within the topics of:
- R&D Management
- QM Systems (ISO, GMP)
- Regulatory affairs (RA)
- Technical documentation
- Verification & Validation
- Commercial, Administration & Finance
Ralph Schäfer, Lawyer
Legal advice and guidance for the MedTech industry, economically evaluated: MDR, Borderline Products, Corporate, Transactions, M&A
MT Consult – Consulting Engineers for Medical Technology – is an international R&D service provider, regulatory affairs expert group and innovation/business development consulting firm exclusively for the medical device industry. We are supporting the innovation-, development-, and product approval processes of our customers mainly for high risk applications and for life-sustaining medical devices.
adjutem covers the missing link between product development and serial production. Our services include design transfer consultancy for both, small companies new to the medical device market as well as global players with a long product history.
We are specialized in class IIa, IIb and III devices with strict design and document control requirements. Our focus is on single-use products with complex functionality where we support our clients to transfer product design to mass production in-house or, in most cases, at leading contract manufacturers.
Our consultants have application-specific knowledge in neurosurgery, cataract surgery, ENT, ventilation, drug delivery and implants so that we are familiar to build-up technical files and design dossiers in these fields.
CERES employs scientists, engineers, statisticians, and clinicians with years of international experience in relevant clinical, pre-clinical, and technical fields. In cooperation with physicians in several European nations, we conduct successful clinical studies and conclusive clinical evaluations for medical devices.
Information & Training
The product can stay on the EU market with an ‘old’ CE marking until 2025 at the latest, depending on the product. The timelines for transition will have to be set on a case-by-case basis. As classification rules change, some products currently considered as Class I or even not in the scope of the directive (eg. aesthetic lenses) or under auto-certification process (eg IVDs classified as ‘others’) might be upgraded to higher classes for which certification by a NB will be required.
Every manufacturer must perform proper due diligence to adapt their regulatory strategy and quality systems accordingly.
Manufacturers of CE-marked devices according to the MD directive 93/42/CE will have to update some of their processes and procedures, especially for post-market surveillance and post-market clinical follow-up during the transition period (mid 2017 to mid 2020) in order to get ready once the directives are fully replaced by the MDR and IVDR. Operational modalities for the submission of the annual CERs for review as well as the expected format or precise expected content are not yet defined. This will clearly be challenging for the authorities and the manufacturers.
- Anforderungen für den internationalen Marktzugang
- EMV-Abhilfemaßnahmen aus der Praxis für Entwickler
- EMV- und Funkanforderungen für Wireless-Systeme
- Sicherheit medizinischer elektrischer Geräte und Systeme nach IEC 60601-1
- Neue EMV-Anforderungen für Medizinprodukte nach EN 60601-1-2
- Anforderungen Produktsicherheit für IT / AV Geräte nach IEC EN 62368