In order to market medical devices in Europe, they must comply with the applicable regulatory requirements. The European Council has approved the new medical device regulations MDR 2017/745 (formerly MDD 93/42/EEC and AIMD 90/385/EEC) and the in vitro diagnostic medical device regulations IVDR 2017/746 (formerly IVDD 98/97/EEC), which are in force since 2017.
These new Regulations mainly incorporate:
- New rules for the classification of products.
- Improved clarity of the requirements compared to the previous Directives.
- Clearer rights and responsibilities for economic operators are established.
- Stricter supervision of Notified Bodies.
- Stricter provisions for post-market surveillance.
- From May 2020, it will affect non-medical products listed in Annex XVI of the MDR.
- Products that under the MDD and IVDD directives did not require Notified Body assessment, now DO require it under MDR and IVDR.
Therefore, all economic operators that manufacture, group, sterilize, distribute and import medical devices must review the degree to which the entry into force of the new regulations affects them.
In Azierta we support manufacturers to obtain the CE marking of medical devices according to the new Regulations or to update their product certifications to the new requirements.