Regulatory Update: Medical Devices

With a three (3) year transition period, the European Medical Device Regulation (MDR) replaces the current Medical Device Directives from May 26, 2020 on. Article 120, however, allows legal device manufacturers continued market access of legacy devices with a valid Directives based CE-Mark certificate latest until May 26, 2024; but only within the regulatory framework of the new MDR Post-Market Surveillance (PMS) requirements becoming effective as of  May 26, 2020. 

Figure 1: MDR Transition Timelines for Medical Devices (Source BSI UK)

• While a continuous and thorough data collection, analysis, evaluation and reporting of post-market surveillance information is at the very heart of this change, these new European Regulations introduce more incisive and prescriptive measures based on device risk levels for the MDR.
• Annex III  of the describes explicitly what kind of information must be included in a PMS plan that is part of the device specific Technical Documentation including appropriate and effective QMS processes, methods and tools.
• While some of these requirements were previously provided as information only in non-binding guidance documents, they are now mandatory to establish legal compliance with the European Medical Device Regulation. 
• Annex  III makes explicit reference to Post-Market Clinical Follow up (PMCF) Planning content requirements in Part B of Annex XIV.  The main purpose of a PMCF plan is update the device specific clinical evaluation report (CER) in defined intervals utilizing systematic processes and appropriate methods to continually collect, analyze and evaluate valid clinical data from the commercial use of a CE-marked device within its intended purpose and indication.  

• The main objective is to confirm continued patient safety, intended clinical performance and patient benefit(s) of the device throughout its expected lifetime.

• The implementation of the PMS plan can result into two (2) different type of post-market reports based as outlined in Table 1:
   

• The above post-market reporting requirements imply a new type of additional periodic assessments by the involved Notified Bodies to maintain the CE-Mark Certificate. It remains unclear, what parts of the PSUR information may become public information available to interested stakeholders such as patients, user facilities and health insurers.
• The  European MDR regulatory framework consolidates the defragment content form MEDDEV Guidance documents for Post-Market Surveillance (PMS), Vigilance and Post-Market Clinical Follow (PMCF) Up into mandatory European regulatory requirements for all medical devices carrying a valid CE-Mark.
• These new PMS requirements will become mandatory for Medical Device Manufactures from May 26, 2020 on and must therefore be carefully assessed against implemented QMS procedures, processes and data collection tools to identify existing gaps allowing for a forward-looking implementation of additional procedural content requirements, reporting formats and timelines.

[1] A National Competent Authority or Notified Body may request PMSR at any time.