The two EU medical devices regulations, the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), were published in the European Official Journal on 5 May 2017 and entered into force on 25 May 2017. The effective date, i.e. the date from which the new regulations alone are valid, and the old legal framework becomes invalid, is generally 25 May 2020 (3 years transitional period) for the MDR and 25 May 2022 (5 years transitional period) for the IVDR. EU regulations apply directly and as a matter of priority. This means that no transposition into national law is necessary. It should be noted that many requirements require the full functionality of the European database for medical devices (EUDAMED). If the full functionality is not given, the corresponding provisions of the directives continue to apply.

NSF International informs its customers immediately about such planned changes. In addition, the impact of such changes on medical devices already on the market is identified and evaluated. Through market observation, hospitations, customer surveys, competitor observation and evaluation of complaints, data is collected in order to avoid unnecessary retrospective activities.

Our consultants evaluate technical solutions through risk assessment and clinical evaluation and support you in determining possible immediate, corrective or preventive measures (C/CA/PA).

When does a medical device become a medical device?
These and many other regulatory questions concern manufacturers when dealing with topics such as intended use, approval, registration and target markets.

Pharmaceuticals and medical devices are subject to different legal frameworks in Europe. Your challenge as a manufacturer is the regulatory classification of your product. This requires a precise delimitation at an early stage of development. As a result, the tests required to confirm marketability are completely different for these two product classes. Even in the case of combination products consisting of a drug and medical device component, it is necessary to clarify under which law the product is regulated.

How We Can Help
Use our experience in the preparation of delimitation reports for submission to authorities or notified bodies as a basis for discussion and decision-making in delimitation and classification issues for your product.

We would be pleased to prepare expert opinions for you. Our team and network of proven experts are at your disposal for this purpose. We see ourselves as an independent partner that examines issues on a scientific basis and in the light of the existing regulatory environment. With these activities we would like to contribute to the success of your projects and optimize the discussion between you and the authorities.