Regulatory
Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD).
Far from being a good moment for manufacturers to rest on their laurels, they should be urgently addressing PMS. PMS requirements under the MDR have in fact been applicable since 26 May 2021 for all medical devices sold into the EU, regardless of a device’s MDR CE Marking status. Certain PMS requirements are in fact also applicable to legacy devices on the market under the MDD or AIMDD. Such requirements cover the obligation to draft a complete PMCF plan in addition to a detailed PMS plan, plus cyclical PMS reports for Class I devices or PSUR reports for Class IIA, IIB and Class III devices. Class IIA devices require the PSUR to be updated at least every two years, whilst Class IIB and Class III devices require the PSUR to be updated at least annually.
PSURs are required to be submitted to the Notified Body (NB) at least annually (IVDR Article 81) for IVDs that are Class C and Class D, while PMS reports will be required for Class A and Class B IVDs which are to be made available to Competent Authorities and NBs upon request and updated as needed (IVDR Article 80). Best practice examples clearly indicate that these should be reassessed and updated every 12 months. At time of writing, all these proactive PMS measures have been a requirement for IVDs since May 2022. With the new MDR, it is no longer sufficient to only address issues further to a complaint, but
manufacturers must gather clinical and safety-related data after completion of the CE certification process, approval and market access. The objective is the prevention of problems for better patient safety, but manufacturers that adhere to a rigorous PMS system can also reap important commercial benefits. A thorough process of market intelligence canvassing and data collection can in fact lead to greater customer confidence, improved brand awareness, a reduction in complaints, as well as administrative and compensation savings relating to managing these issues. Efforts to comply with the MDR can even prove useful for export strategies outside of
Medical Device Developments /
www.nsmedicaldevices.com
“A thorough process of market intelligence canvassing and data collection can in fact lead to greater customer confidence, improved brand awareness, a reduction in complaints, as well as administrative and compensation savings.”
the European market, where PMS is also a requirement. While non-negotiable and greatly beneficial to overall business profitability, the onus of the activities covered by PMS cannot be overlooked. PMS is a cyclical process that requires significant man-hours and the support of highly specialised staff.
Digitalization from Shop Floor to Top Floor
Quality Management Software
www.CAQ.de
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