Stiffer safety and performance checks on the horizon for medical device manufacturers

Out-Law News | 29 Jun 2015 | 10:34 am | 2 min. read

Medical device manufacturers will be subject to stiffer safety and performance rules, under new proposals backed by EU ministers.

The Council of Ministers, which brings together the national governments within the EU, has voted to approve proposed new medical device regulations (194-page / 1.33MB PDF) and will now open talks with MEPs in a bid to agree final wording for the reforms.

Under its proposals, medical device manufacturers will be required to "plan, conduct and document a clinical evaluation" of their products to demonstrate they meet safety and performance requirements before those devices can be put on the market or used in the EU.

"The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate compliance with the relevant essential requirements on safety and performance which shall be appropriate to the characteristics of the device and its intended purpose," the proposals said.

Manufacturers will in some cases also have to ensure their devices are assessed for conformity with the new rules by independent 'notified bodies', whose activities would be overseen by regulators, before the devices can be sold or used in the trading bloc, according to the plans.

In a statement, MedTech Europe raised concern with the Council's proposals on pre-market checks which it said are "redundant" and "only serve to adversely impact the innovation and growth of the medical device industry".

If the device makers are based outside the EU, they will need to appoint a "single authorised representative" (SAR) and give that person or business a mandate to perform certain tasks or act on its behalf. The SAR would be responsible, among other things, for verifying declarations that the manufacturer's device conforms to the EU rules and for cooperating with regulators "on any corrective action taken to eliminate the risks posed by devices".

Medical device manufacturers would also have to put in place a "post-market surveillance system" (PMSS) to ensure that faults with their devices can be identified and corrected after they have been put on the market.

According to the proposals, the PMSS must be "suitable to actively and systematically gather, record and analyse relevant data on the quality, performance and safety of a device throughout its entire lifetime, to draw the necessary conclusions and to determine, implement and monitor any preventive and corrective actions".

The Council's proposals, if introduced, would also introduce new reporting obligations. Manufacturers of medical devices would need to be able to track incidents stemming from their devices when in use and to notify regulators immediately "where the device presents a serious risk".

New rules to help individual medical devices to be identifiable have also won support from the Council. The 'unique device identification' (UDI) regime would apply to all medical devices other than those which are custom-made or 'investigational', and would enable "unambiguous identification of specific devices on the market", the proposals said. A new UDI database would be established to "validate, collate, process and make available to the public" information about the devices in the market.

A 'medical device' is defined, under the Council's proposals, as "any instrument, apparatus, appliance, software, implant, reagent, material or other article" that manufacturers intend people to use for one of a range of specified medical purposes. Those purposes include "diagnosis, prevention, monitoring, treatment or alleviation of disease", injury or disability, and the "investigation, replacement or modification of the anatomy or of a physiological or pathological process or state".

"[This] agreement is a decisive step forward to improve patient safety and strengthen European competitiveness," said Guntis Belēvičs, minister for health in Latvia said. Latvia is the current president of the Council of Ministers. "Further work both within the Council and between the Council and the European Parliament is, however, needed to ensure that the benefits of the new rules are put into practice."