This is a guest post by Caroline Jung of MT Promedt Consulting GmbH from Germany, a partner of Stendard.
Part 2 of our 6-part series to give you an overview of the main points or changes to the MDR in light of legislation and new regulatory requirements.
The new MDR (EU) 2017/745 is an enormous challenge for the manufacturers of medical devices.
In this article, we will highlight the most important requirements concerning legal manufacturers.
Meeting the transition deadline
First of all, it should be pointed out, that the transitional period ends after three years (on 25 May 2020)! This means that companies have less than one year left to become compliant to the new regulation.
It needs to be understood, that even if the CE certificates issued under the MDD 93/42/EEC fall under a grace period, which ends latest in May 2024, manufacturers have to cover the general requirements described in the MDR from May 2020.
From 26 May 2020, manufacturers of products which are classified higher than Class I must be able to present an EC certificate according to the new MDR when placing their medical device on the EU market for the first time.
If a manufacturer cannot prove that the product placed on the EU market is in conformance to the MDR as soon as the regulation becomes valid, the competent authorities may prohibit the placing of the medical device on the market.
Obligations of manufacturers
Article 10 of the MDR lists the general obligations of manufacturers. It provides references to further articles and annexes of the regulation, which describe the responsibilities in greater details.
Certainly, manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
Other main obligations for manufacturers to note regarding the MDR include:
- Maintaining a structure of Technical Documentation according to Annex II and Annex III,
- Appointment of a Person Responsible for Regulatory Compliance (PRRC),
- Higher demands placed on the compilation of clinical data, for example in clinical evaluation and post market clinical follow up,
- Intensified activities and additional reporting with regards to Post Market Surveillance (PMS) and Post Market Clinical Follow Up (PMCF), as they will become mandatory,
- Additional labelling requirements as an UDI (Unique Device Identification) system will be introduced for each product.
- The manufacturer needing to be registered in the EUDAMED database and have a Single Registration Number (SRN).
- Product liability requirements. In case of any claim related to a compensation request due to a damage caused by a defective device, manufacturers have to assure financial coverage.
As you see, it is very important, that you, as a manufacturer get familiar with the new requirements in the MDR (EU) 2017/ 745. Therefore it is very important to study in details the new MDR.
Having a deep knowledge will avoid unnecessary trouble with regards to placing your product on the European market.
The right perspective
The new legislation can also be seen as a great opportunity for manufacturers to restructure and improve their entire organisational processes and procedures. This raises confidence for customers, regulators and many important stakeholders of the company, and accelerates global growth. For manufacturers who see this opportunity, it will be a significant competitive advantage.
It is important for your manufacturers to prepare well and be ready for the new MDR requirements!
We will be sharing more about the above points in our upcoming blog posts, stay tuned to find out more!
