MDR COMPETENCE

Your Medical Device Consulting Group … we safely navigate you through the troubled MDR sea …

The Medical Device Regulation (MDR)

The transition period MDD to MDR has ended on May 26th, 2021. Now, the new Medical Devices Regulation (MDR) (EU) 2017/745 is fully enforced and replaces the previous Medical Device Directive (MDD) 93/42/EEC.

In Germany, the new Medizinprodukterecht-Durchführungsgesetz (MPDG) has replaced the former Medizinproduktegesetz (MPG). The MPDG is intended as a complement to the MDR.

As a help for implementation of the MDR requirements the Medical Device Coordination Group (MDCG) was established in accordance with article 103 of the MDR. Not all planned guidance documents are already available, therefore all economic operators are advised to keep an eye on the actual situation of these documents.

Under the MDR, medical device companies will have to:

  • provide substantially more clinical evidence to get products to market, or even to keep some products on the market
  • conduct deep portfolio audits to determine the impact of the MDR on the margins for products currently CE marked under MDD, if not done so far
  • be aware to adapt the labeling of products according MDR specifications which still have to be implemented by entities designated by the European Commission (e.g. UDI)

You as manufacturer, importer, or distributors have to be aware of your enhanced role and your additional obligations and responsibilities!

Among many novelties introduced by the MDR, one focus is set on cybersecurity. The MDR requires the manufacturers to develop and manufacture their products in accordance with the state of the art taking into account the principles of risk management, including information security, as well as to set out minimum requirements concerning IT security measures, including protection against unauthorized access. This requirements for cybersecurity must be ensured throughout the entire life cycle of the medical device.

Another focus of the MDR is the technical documentation and the technical documentation on Post Market Surveillance, which have been expanded and have now more detailed requirements.

Our network services

We – as a consulting network – could support you as our potential client in:

  • providing guidance to quality and risk related questions
  • supporting creation of a MDR compliant technical documentation according to Annex II of MDR
  • The new ‘scrutiny’ process
  • supporting due diligence activities and M&A activities
  • providing guidance to clinical trial planning and clinical evaluation reporting
  • providing guidance to actual EMC test requirements
  • Cybersecurity (CS) Training for medical device manufacturers
  • Cybersecurity Conformity Assessment Body Services

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.

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

Dirk Meier

Regulatory Affairs (MDD/MDR)

Ralph Schäfer

Medical Device Law, Corporate Law, M&A

Stefan Bock

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

Josef Bauer

Guest-Member

Bernd Auer

Cybersecurity (CS) Training for medical device manufacturers / Conformity Assessment Body Services

Become a Member

 In case you or your organization would like to join the MDR-Competence Network feel free to contact us.

Areas of Expertise

Nanoconsult

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:

  • Toxicology
  • 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)


RegConsult

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.

Fraunhofer ITEM

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
  • Interim-Management
  • Innovations-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

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 GmbH

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.


Training and Conformity Assessment Services

Cybersecurity (CS) Training for medical device manufacturers

  • Introduction into CS, regulatory requirements across main markets and related standards (FDA, MDR, MDCG 2019-16, UL 2900, IEC TR 60601-4-5)
  • CS Threat Analysis & Risk Management for Medical Device Manufacturers (STRIDE, ISO 14971, AAMI TIR 57)
  • CS Post-Market Activities (FDA, AAMI TIR 97, MDCG 2019-16)
  • Secure HW/SW Development Lifecycle
  • Secure design & coding, vulnerability assessment & testing
  • Communication & network security

Conformity Assessment Body Services

  • CS testing and assessment of components and devices
  • CS related pre-testing services against proprietary specifications or relevant standards and guidance documents
  • Independent CS related conformity testing and assessments against relevant standards and guidance documents
  • Independent CS related conformity testing and reviews as requested in MDR (REGULATION (EU) 2017/745) Annex VII 4.5.3 f)

CERES GmbH

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

Products already CE marked under MDD can still be sold, as long as their granted CE mark is valid or at latest until May 26th 2025, depending on the product. As classification rules changed, some products formerly considered as Class I or even not in the scope of the directive or under auto-certification process might be now upgraded to higher classes for which certification by a NB is required.

Some manufacturer still must perform proper due diligence to adapt their regulatory strategy and quality systems accordingly.

For example, as requirements on clinical data from equivalent devices have increased significantly compared to the requirements of MDD they are becoming less and less accepted. Therefore, the collection of own data, like a Post Market Clinical Follow-Up (PMCF) study and/or other clinical data, became more and more important and have to be implemented in an appropriate PMS system.

Requirements for the PMS system documents also became stricter and more extensive in general, like:

  • PMS plan (needed for all classes)
  • PMS report (needed for class I)
  • Periodic Safety Update Report (PSUR) (needed for class IIa, IIb, and III)
  • Summary of Safety and Clinical Performance (SSCP) (needed for class III and implantable devices)
  • PMCF plan and report (needed for all classes)

These documents have to be kept updated proactively during the whole product lifetime.

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Trainings on EMC and product safety

  • IEC 60601 ed.3.2 – Important Updates and Considerations to be prepared for testing
  • EMC Requirements for Active Medical Devices/Systems according to IEC 60601-1-2 Ed. 4 / Ed. 4.1
    Module – General Introduction of IEC 60601-1-2 ed.4 / ed. 4.1 requirements
    Module – How to setup an EMC Testplan for IEC 60601-1-2 ed.4 / ed. 4.1
    Module – Risk Management Requirements from IEC 60601-1-2 ed.4 / ed. 4.1
  • Product Testing and Certification – Requirements for international market access
  • Introduction to International Wireless Product Certification
  • Integration of wireless modules – EU Requirements
  • Online Crash Course: CE Declaration for Electronic Products
  • Product safety requirements for electrical equipment for measurement, control, and laboratory use according to IEC 61010-1
  • Product safety requirements for Audio/video, information and communication technology equipment according to IEC 62368-1

Contact

MDR Competence – Your Medical Device Consulting Group
Heinrich-Heine-Gärten 6
40549 Düsseldorf
Germany


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