Qualified experts in the field of UE market access

Use the services of the qualified MDR Regulator team to help in your product launch on the EU market.

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SUPPORT IN A KEY MATTER

MDR Regulator – your trusted consultancy partner in the medical industry

We will help your business enter the European market of medical devices and equipment.

We will propose solutions allowing you to place the product on the market, including: legal representation as an Authorised Representative in Europe, Person Responsible for Regulatory Compliance, documentation review, product registration, distribution and marketing support in the EU market.

Industries

Medical devices

Medical
devices

Medical devices benefit patients and users by helping to diagnose and treat patients and to prevent diseases, improving quality of life.

In vitro diagnostic medical devices

In vitro diagnostic medical devices

In vitro diagnostic medical devices, by examining a sample of tissue or body fluids, effectively and safely diagnose a number of diseases or conditions.

Food supplements

Food
supplements

Dietary supplements in Polish regulations are significantly different from medicinal products, which affects their scope of application and restrictions.

Personal protective equipment (PPE)

Personal protective equipment (PPE)

Personal protective equipment is a product that protects users from mechanical injuries.


FULL SUPPORT

Follow us through the entire certification process

MDR Regulator offers a full range of services enabling medical device manufacturers to place their products on European markets and to ensure continuity and compliance of their operations with applicable European laws.

A company can use MDR Regulator's services at any stage of product launch - from design, through implementation, testing, documentation, certification, registration or notification, and post-market services (distribution, marketing, market surveillance and other activities).


MEET US

Let's talk about cooperation

As a team of medical market specialists, we have a unique combination of experience in legal regulations, auditing, medical technologies as well as in business management and marketing. Thanks to our knowledge and experience, we are able to efficiently introduce the product to the EU market.

Katarzyna Wesołowska

Chief Executive Officer

Katarzyna Wesołowska

A graduate of Biomedical Engineering at the Warsaw University of Technology and Clinical Research Methodology at the Medical University of Warsaw. Since the beginning of her career, she has been working in the medical industry. She has gained professional experience in healthcare companies and in the Notified Body. Active CE and ISO 13485 Auditor.

She knows how to effectively implement the MDR. Always looking for non-standard solutions.

Specialisation in areas:
  • MDR,
  • Authorised Representative UE,
  • Clinical evaluation,
  • CE Marking,
  • Quality Management Systems,
  • Non-EU market access,
  • Audits,
  • Trainings.

Adrianna Pyrzanowska

Project Manager

Adrianna Pyrzanowska

A graduate of a Public Health. She has gained experience in the field of medical devices in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, as well as by implementing many projects related to the introduction of medical devices on the market, providing support in the conformity assessment process.

She coordinates cooperation between MDR Regulator’s experts and clients.

Specialisation in areas:
  • IVDR,
  • Person Responsible for Regulatory Compliance,
  • UE product registration,
  • CE Marking,
  • Import and distribution,
  • Dietary supplements.
POSITIVE FEEDBACK

Recommendations

MDR Regulator always offer the highest levels of services provided. Here are some newest recommendations from our clients who clearly believe in our experience, commitment and full support in projects implementation.

Qualified team

“We have been cooperating with MDR Regulator Sp. z o. o. in terms of preparation the Technical Documentation to MDR and detailed consultations in terms of meeting legal requirements and harmonised standards for active medical devices. We assess the cooperation with MDR Regulator as very good. The company has qualified and competent personnel and the cooperation is going according to our expectations. Our comments and suggestions concerning the cooperation are taken into account on an ongoing basis. We could highly recommend services of MDR Regulator.”

Zepter International Poland Sp. z o. o.

Individual approach

“We recommend working with MDR Regulator to prepare the Technical Documentation and Quality Management System for MDR requirements. The MDR implementation strategy was carefully planned and the presented results leaves no room for doubt. What we particularly recommend is the individual approach to the topic, through adapting the solutions to the structure and business activity of our company.”

Reha Fund Sp. z o. o.

Very active and professional

“We have appointed MDR Regulator Sp. z o. o. as the Authorized Representative for our class III medical devices with CE mark on the European Union Market. We have been working with MDR Regulator Sp. z o.o. since last year. During this time they are very active and professional in their role, and have never disappointed us in terms of their service. So we are planning to continue our relationship with them in the future as well. We would highly recommend you MDR for their all service.”

RFBio Co., Ltd.

Efficient and fast approach

“MDR Regulator’s efficient and fast approach allowed us to enter our products to the EU market. The MDR Regulator team helped us with lab testing and evaluation, then assisted us with technical documentation and product registration. We can sincerely recommend their services.”

Zep Medical
WE HAVE TRUST

Values of MDR Regulator

As a company that contributes to building one of the most important sectors of the economy, we are guided by the principles of transparency and honesty in our work with clients.

Honesty and transparency

Our work with clients is based on such values as:

  • building long-term relations based on clear and transparent rules of cooperation,
  • responsibility for the decisions made,
  • ensuring competitive advantage,
  • using all possible development tools,
  • taking up challenges.

Professionalism

MDR Regulator is built by a group of specialists with long-standing experience in legal regulations, medical technologies, lobbying, business management and marketing. We have knowledge concerning all risk classes of medical devices and borderline products, as well as experience in cooperation with notified bodies, competent authorities, accreditation bodies and the European Commission. We are well aware of the process approach to quality assurance according to ISO 13485 and ISO 9001, which is very important in the medical industry. Our activity relies on a highly qualified team, whose members – as part of sustainable development – constantly improve their qualifications, as well as openness to new solutions and development paths.

Learning by doing

By listening to our clients’ needs, we are able to continuously expand our team of professionals and offer services enabling further optimisation of the process of placing new medical devices on European markets.

News

Latest industry news and developments

May 26, 2021

26 May 2021 – MDR is fully applicable today!

On 26 May 2021, the MDR has been fully applicable, following the transition period. If you are a Manufacturer, Importer or Distributor of medical devices, or have other responsibilities under the MDR,...

Katarzyna Wesołowska,   Chief Executive Officer
March 26, 2021

MDR requirements for custom-made medical devices

The Medical Devices Coordination Group (MDCG) established under Article 103 of Regulation (EU) 2017/745 published in March 2021 recommendations regarding the qualification of adaptable mass-produced m...

Adrianna Pyrzanowska,   Project Manager
January 20, 2021

MDR and MDD Differences – what is going to change in May 2021

The new MDR Regulation (745/2017) compared to the current MDD (93/42/EEC) and AIMD (90/385/EEC) is much more extensive and detailed - it contains 123 articles and 17 annexes - which is more than 175 p...

Katarzyna Wesołowska,   Chief Executive Officer
January 18, 2021

How BREXIT affects the export of medical devices to the UK?

From 1 January 2021, the United Kingdom is out of the customs union ,the single market of the European Union and ceased to be bound by EU law. Until the last few days, it was unclear how the UK's coop...

Katarzyna Wesołowska,   Chief Executive Officer
CONTACT US