Newsletter No 1 March 2019
Subject: MDR Readiness at STS Medical Group
The new Medical Device Regulation (MDR) – marking a big change in product release for the European Medical Device Industry – is approaching the date of application.
We at STS Medical Group, as one of the leader in the kit packing business, wish to kick off a dialogue with our customers. We want to inform everyone with a monthly newsletter on specific topics around the new regulation and give you full transparency on our efforts to ensure that our products will continue to be available beyond the implementation date.
These newsletters will give you some transparency towards our activities “behind the scenes” and support you to better classify the ongoing discussions around the new regulation. We will try to pick for each newsletter some “hot topics” and aim to be very close to the current developments in the area.
When is the date of application?
The date of application (DoA) for the MDR is 26 May 2020. This is exactly three years after the date the regulation entered into force after publication in the official journal of the European Union. This resulted in a very short implementation period for the medical device companies, especially as there were only few guidance documents for the interpretation of the new requirements available at the time of release. Moreover, all Notified Bodies need to get an accreditation for the new requirements before they can certify product for compliance to the regulation. As of today only one Notified Body, the British Standard Institute (BSI) in UK got the accreditation (in January 2019). This highlights one goal of the revision of the Medical Device legislation: requirements towards the Notified Bodies have become much stricter. The accreditation process now consist of an audit by a joint assessment team (JAT), subsequent corrective actions and finally the formal designation by the National Competent Authority. The JAT is composed of three experts: one from the Commission and two from Member States other than the one in which the applicant conformity assessment body is established. With this, the accreditation process is no longer under the supervision of one national authority alone and this is expected to level out current differences in the quality of the accredited Notified Bodies across Europe. You might have followed the discussions, that due to that bottleneck of accredited Notified Bodies the DoA might be postponed. In a debate in the EU Parliament in October last year the commission clearly stated that they see still all on track and do not intend to change the transition period.
Will all devices have to comply with the new Regulation after 26 May 2020?
Products on the market with valid certification according to MDD may be marketed as long as the MDD certificates are valid. For our products, these are the EC certificates and these will be prolonged to a validity until 2024. The new requirements apply to new medical devices (released after 26 May 2020) or to devices that can be marketed without a certificate – the class I devices. It is interesting that with this, the compliance date for the low risk devices is actually before that of higher risk class devices. It is also important that the compliance date for already marketed class I devices, which are sterile or have a measuring function is again linked to the validity of the MDD certificate and not to the DoA. So from the DoA on you will see class I devices with a declaration of conformity according to MDR, whereas sterile class I devices (class Is) might still be placed on the market with a declaration of conformity according to MDD.
So – no change on 26 May 2020 for most of the products?
To increase confusion: many of the requirements in the new regulations relate to quality system aspects and thus are independent of the product certification. Those requirements are binding and need to be implemented for all products with the DoA. These requirements are related – among others – to post market surveillance and vigilance reporting, requirements for labelling and making specific device information publicly available once the European Database for Medical Devices (EUDAMED) has been established. For example all products need to have a unique devise identifier (UDI) assigned, which will later also be displayed on the products and will allow for better traceability of the device throughout Europe.
What is STS Medical Group doing?
STS has assigned a substantial budget and initiated a corporate wide project coordinating the activities towards the compliance of our products with the new requirements. The activities are broken down to specific work packages led by different function in our company.
The major work packages are:
Post Market Surveillance and Vigilance
Quality system requirements
For the next mailings in this series, we will pick some topics from these areas and give you a more detailed insight into the requirements and activities. Would you like to learn more about specific topics? Do you have comments or questions?
CEO STS Medical Group
Dr. Barbara Malitschek
Corporate Director Regulatory Affairs