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On the 26th May 2021, the transition period for manufacturers to place new medical devices on the market certified according to the Directive 93/42/EEC (MDD) ends.
As of today, to place medical devices on the European market, it will be necessary to CE mark them according to the new MDR 2017/745. The certification process under the new MDR 2017/745 sets stricter requirements for manufacturers wishing to market their devices within the EU market.
The MDR certification process, likewise the MDD process, involves the following steps:
- Document Review (Technical File, Clinical Evaluation Report, Quality System Manual),
- On-site Audit, after the closure of non-conformities of phase 1,
- Final Review and Issuance of the EC certification, after the closure of non-conformities of phase 2.
During phases 1 and 2, important delays can occur due to any non-conformities found. In order to avoid such concerns, Companies should proceed with a pre-assessment of the document, so to make sure to start on the right foot the CE marking process of the product according to Regulation (EU) 2017/745.
The aim of the gap-analysis is to outline the gaps that the manufacturer will need to fill in order to meet the requirements of the MDR.
Another key factor for manufacturers who want to make sure to be prepared for the certification process is training.
In order to move smoothly through the complexity of the MDR regulatory requirements, it is necessary to strengthen your resources. Only through an in-depth knowledge of the subject it will it be possible to face the certification process with awareness and confidence.
ECM Divisione Academy offers a wide range of training courses to allow companies and professionals to improve their skills, in order to operate with greater efficiency and professionalism.
To find out more about our services dedicated to the new Regulation 2017/745 (MDR), contact our Sales Manager Antonio Balassone at antonio@entecerma.it | cell. (+39) 393 2471040
