Introduction to PMS and definition

Post marketing surveillance (PMS), also known as post market surveillance, is the practice of
monitoring the safety of a pharmaceutical drug or medical device after it has been released on the
market and is an important part of the science of pharmacovigilance. A report was issued by Global
Harmonization Task Force which describes the clarity of specific tasks needed for post-market
surveillance in the manufacturing industry and discussed the requirements for each task that could
be harmonized across regulatory environments. This report was afterward upgraded by the
International Medical Device Regulators Forum (IMDRF) to expand on announcing rules for adverse
events.

Medical device post-market Surveillance activities have been explained in the European Medical
Device Directive MDD (93/42/EEC) and are part of the Quality Management System (QMS)
certification under EN ISO 13485:2016. However, the EU’s Medical Device Regulation (MDR) was
officially published on 5 May 2017 and came into force on 25 May 2017 and the new MDR has been
replaced the EU’s current Medical Device directive (93/42/EEC). Currently, many NB’s are
undergoing the MDR Notified Body designation process which needs to be successfully completed
for a NB to be allowed to undertake certification to the MDR.

PMS MDD to MDR transition

The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR)
within the European Union (EU), is progressing to the original timescales as circulated by the EU. The
amendment of the MDR was published in April 2020, and MDR which came into effect in May 2017.
MDD to MDR transition date was 26 May 2021, and Medical Device Directive has been replaced by
the new Medical Device Regulation. MDR is designed to be an improved version of MDD, with the
important change being that of MDR influence and provides effectiveness to all EU member states.
Medical device manufacturers and notified bodies prioritized reviewing all technical files to the new
directive in the fear of backlogging of certifications. The manufacturer will be assessed according to
the regulation and will thus require a new certificate for their device and product. The device which
has been certified under MDD can continue to be placed on the market until the current certification
expires. New MDR is four times longer than the MDD, and focusing more on product safety. Any
medical devices which did not get approved to the MDR after this time cannot carry the CE mark and
cannot be marketed in the member states of the EU. MDR improves the standards' quality and
safety measures.

PMS Planning and challenges

 The new MDR and IVDR regulations came into force which replaced MDD, AIMD, and
IVDD. It has put pressure on all the medical devices industry. The transition includes
some of the important aspects like promoting a shift from the pre-approval stage to
a life-cycle approach, device classification changes, independent assessment bodies,
better traceability and extended EUDAMED Database on medical devices and
Conformity Assessments.
Due to global COVID-19 pandemic there was one year extension of Medical Device
Regulation (MDR). The delay created challenges for medical device manufacturers and the
notified bodies (NBs). Benefit to the manufacturers and NBs is that they received time to
adapt the new transition. The manufacturers in following position have the most gain by 1
year delay:
1. Class I Devices with Significant Changes: The grace period essentially means that
qualifying class I devices do not need to be certified to the new MDR regulation but instead
can utilize the MDD Declaration of Conformity (dates).
2. Renewal of MDD Certification: Manufacturers who needed more time to renew their
Medical Device Directive (MDD) received some breathing room.
3. Notified Bodies: European Commission and EU Member States will have an
additional year to accredit NBs under the MDR. The NBs are fewer than the original
projections and have gained some time to align the process.
It has also led to some challenges like hurdle because of the class I manufacturers have not
been used NBs in past, allowing NBs to conduct virtual audits for MDD renewal was critical,
all focus toward the new MDR was not possible and most of the NBs are focused on
renewals and may not have enough time or resources to transition from MDD to MDRs.
After Brexit's transition period, high import tariffs, duties, and taxes increased the cost of
the device, making them less competitive in both the UK and the EU. The Medicines and
Healthcare products Regulatory Agency (MHRA), which regulates medical devices marketed
in the UK, released new guidelines in September 2020. The new rules will be applicable for
placing medical devices in Great Britain, Northern Ireland, and the EU.