Regulations for Medical Devices

1. Revised EU Rules specific to safety of medical devices

EU’s two new Regulations on medical devices (Regulation (EU) 2017/745, ‘MDR’) and in-vitro diagnostic medical devices (Regulation (EU) 2017/746) were adopted in April, modernizing the legislative framework for healthcare equipment and strengthening the protection afforded to patients across the EU.

Replacing the two original Directives which were in place for some 20 years and as such were outmoded, the regulations were finally passed after 5 years of scrutiny by the Parliament and Council.

Changes to expect under the new regime

Healthcare equipment manufacturers and other actors within the product supply chain face a number of significant changes in the regulatory landscape in terms of stricter controls and a regulation with greater reach/scope.

Aspects which will impact on the production of a compliant product:

  • Increased market surveillance and traceability;
  • Tighter controls on high-risk devices;
  • Tighter controls on clinical trials/evaluation;
  • Extension of scope to cover aesthetic products;
  • New system for risk classification;
  • Mandatory unique device identifier (UDI) requirement for every product to permit enhanced product traceability;
  • Collection of performance data by manufacturers;
  • Publicly-available information on European Database of medical devices (EUDAMED).

The enactments represent a major regulatory shift in the EU and will necessitate changes to the way medical device manufacturers bring their devices to the European market, along with the process of maintaining a state of compliance throughout the product’s life cycle.

The regulations are scheduled to enter into force on 25 May, from which a transition period of 3 years will run, with manufacturers obliged to fully apply the new rules from May 2020.

The Regulation on in-vitro diagnostics will be fully applied after 5 years.

Further points of note:

Liability of authorised representative – For manufacturers who are not established in the Union, the authorised representative will  play a crucial role in ensuring the compliance of the devices produced by those manufacturers and in acting as their contact person established in the Union. For the purposes of enforcement, the authorised representative will be legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations.

Post-market safety – The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should enhance the effectiveness of the post-market safety-related activities for devices.

Information gathering by manufacturers – Manufacturers will be obliged to establish a post-market surveillance system which will actively gather information from post-market experience of their devices. This will enable manufacturers to update their technical documentation as required and cooperate with the national competent authorities responsible for vigilance and market surveillance activities.

EU RoHS2. Proposal to amend RoHS scope 

Medical device manufacturers stand to gain significantly from a critical proposal issued by the Commission in January this year.

Under the current provisions of RoHS, specifically Articles 2(2) and Article 4(3), after 22 July 2019 non-compliant medical devices and test equipment may not be sold, resold or leased, irrespective of when it was placed on the market.

In other words, both the first placing on the market and secondary market operations such as resale, and may involve also the repair, spare part replacement, refurbishment and reuse of non-compliant medical devices will be prohibited after 22 July 2019. The second aspect concerning secondary market operations is especially problematic, since it would require the removal of devices from the market after this date, notwithstanding the fact that they may have been legally marketed in the first place (i.e. before 22 July 2014 for medical devices and 22 July 2016 for in-vitro medical devices).

This block on reselling is known as a “Hard Stop” to secondary market operations and, unless addressed, will cause substantial problems in the industry, with devices becoming waste much sooner than necessary given the impossibility of their repair or refurbishment.

For this reason, the EU Commission proposes to remove the “Hard Stop” to the secondary market operations through the deletion of Article 2(2) and amendment of Article 4(3) in order to allow access to secondary market operations.

The proposal is currently being examined by the EU Parliament’s Economic and Social Committee.

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