On December 16th, 2022, the Medical Device Coordination Group (MDCG) released a new guidance on the Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745. The PSUR has been introduced in Article 86 of the Medical Device Regulation (MDR) 2017/745. The introduction of the PSUR requirement under the MDR requires a more consistent, standardized and systematic review of all Post-Market Surveillance1 (PMS) data by manufacturers of class IIa, class IIb and class III devices.
This is the first document under the new category “PMS and Vigilance”!.
The PSUR summarises the results and conclusions of the analysis of the post-market surveillance data gathered as a result of the Post-Market Surveillance Plan.
The range of PMS data and level of detail of information examined in a PSUR, the modalities for aggregating and assessing the data or the grouping of devices within the same PSUR will depend mainly on the type of device(s) covered, the time span during which the manufacturer has placed them on the EU market and the post-market experience gained with these devices.
The main objective of this guidance document is to assist manufacturers to implement the legal requirements laid down in Article 86 MDR. However, manufacturers should have reasonable time to adapt their quality management systems and sufficient flexibility when they draw up and update a PSUR as long as they can demonstrate that it is in line with Article 86 MDR.
Moreover, PSURs already drawn up or in the process of being prepared when this guidance is published should not be expected to have followed this guidance, as long as those PSURs comply with the legal requirements laid down in Article 86 MDR.
Also on December 16th, 2022, the Medical Device Coordination Group (MDCG) released revision of the guidance on appropriate surveillance regarding MDR Art.120 transitional provisions – devices covered by MDD or AIMDD certificates (MDCG 2022-04 Rev.1).
In this guidance only devices covered by a valid EC certificate issued in accordance with the MDD or the AIMDD prior to 26 May 2021 are addressed. Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR and no later than 26 May 2024 under certain conditions.
The abovementioned conditions require that the notified body that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified. Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 120(3) of the MDR.
To appropriately address application of transitional provisions to devices covered by certificates according to MDD or the AIMDD, this guidance, drafted in line with MDCG 2021- 25 on application of MDR requirements to ‘legacy devices’ and MDCG 2022-15 on appropriate surveillance under IVDR should be read in conjunction with guidance MDCG 2020-3 on significant changes. The first revision of this guidance document is in line with the MDCG position reported in MDCG 2022-14.
In accordance with MDCG position paper 2022-14 (action n.3) in case of MDD devices falling under classes IIa and IIb, notified bodies should discontinue the technical documentation assessments on a sampling basis according to existing sampling plans under the MDD in line with NBOG BPG 2009-4 15 and focus on technical documentation assessments according to the MDR instead. However, deficiencies identified in previous audits need to be followed up.
It further specifies that surveillance activities depending on the specific situation of a manufacturer, audits to be performed under Article 120(3) MDR and audits according to Article 52 MDR and the respective procedures set out in Annexes IX or XI should be combined focussing on assessment of compliance with MDR requirements.
What does this mean to you?
MDCG 2022-21 for all medical device manufacturers that need guidance on PMS and vigilance.
MDCG 2022-04 Rev1. is of interest if you have medical devices that have a notified body certificate under the directive and that is making use of the transitional provisions captured in Article 120 of the MDR. This guidance addresses how notified bodies should oversee legacy medical devices certified under the former Medical Devices Directive or Active Implantable Medical Devices Directive and is in line with the position reported in MDCG 2022-14.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.