Is there a transitional period or does this apply directly?
The new regulations require a completely new certification for all medical devices and manufacturers. During a period, until May 2024 at the longest for MDR, medical devices CE-marked under the current Directive can be put on the market (soft transition). However, depending on the risk class of the product and valid directive certificates, all medical devices will have to comply with MDR or IVDR sooner or later to continue being put on the market. Market access and CE-marking can take place after a new conformity assessment.
Start in time!
To start now, if not done already, it is a must. There are many transitional details, and already amended rules, for manufacturers in the regulatory framework to take into account and plan for strategically. For example:
- Product portfolio review: which products should be transferred to MDR? The status of existing documentation can be crucial in deciding the business case.
- GAP analysis of quality management system processes and procedures, Technical documentation, and inventory classification rules.
- Using the “soft transition”, continue to put medical devices on the market based on the directive certificate, which means no significant changes on the product after May 2021. Does this fit into innovation strategies, market plans, and customer expectations?
- Ensuring competence: training of co-workers and assuring the availability of external experts to the company. MDR requires a Person responsible for regulatory compliance to be employed or to be affiliated with the company, depending on the size of the company.
- Ensure access to appropriate Notified Body (NB): As an increased amount of manufacturers will need a so-called Notified Body, for review of the quality management system and assessment of the Technical documentation, NBs will be fully occupied. Right now, many NBs are busy in designation for MDR/IVDR. In recent years, the number of NBs has decreased significantly, and the pressure on those who remain is increasing.
Knightec can help manufacturers to strategically plan how to and assist in performing the work to meet the new requirements in the best possible way. We have a long experience of making investigations, GAP analysis as well as creating or updating technical documentation, quality management systems, etc. within the Medtech industry. Contact us to find out more.