Dear
Following the COVID-19 pandemic, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR Regulation) was postponed until 26 May 2021.
Entrepreneurs have been given additional time to implement the relevant changes. The MDR introduces new obligations for manufacturers and distributors and sets out in a new way the conditions for the classification of certain medical devices.
In addition, a second version of the draft new law on medical devices was published on 3 July this year. The resumption of work on the draft new Medical Devices Act, taking into account the time remaining until the entry into force of the MDR, is a good time to verify that your company is ready for the upcoming changes.
In order to meet these needs, the Life Science Team of Kondrat and Partners offers you to conduct an audit of the compliance of your company's activities with regard to the requirements of the new Regulation 2017/745 and the new Law on Medical Devices.
As part of the audit, m.in:
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- an indication of the key factors for the trader concerned and his role in the supply chain of regulation 2017/745,
- verification of your certificates,
- verifications of the classification of medical devices,
- analysis of the existing distribution model in the context of the new obligations,
- alignment of contracts with the new rules,
- verification of the labelling of medical devices with a view to the new rules,
- verification and evaluation of advertising materials in terms of new regulations,
- preparation of guidelines for making notifications and notifications under the new rules,
- analysis of selected legal developments in the context of existing activities.
For a detailed quote, enter the quantity and type of products.
We invite you to contact
: tel: +48 22 831 12
34e-mail: audyt@kondrat.pl