Over the past few decades the regulation of the safety of medical devices has remained relatively unchanged. However, today's medical devices are becoming ever more sophisticated and innovative and existing rules have not kept pace with scientific and technical developments. Moreover, the 2011 silicone breast implant scandal and produce recall of the metal-on-metal hip, highlighted serious weaknesses in the current regulatory system and strengthened the case for modernising current rules for medical devices. Following several years of negotiation, new legislation was agreed by all member countries in June 2016 and will become law in late 2019 or early 2020. This week's blog, by Fiona Maini and Sarah Chan from our Risk and Regulatory practice explores the implications of the legislation for the medical devices industry.
The new requirements of the medical devices regulation
The new medical devices regulation (MDR) requires increased scrutiny of products before they enter the market and tighter surveillance once they are in use. It also requires the establishment of a unique device identification (UDI) system to ensure full compliance and traceability; whilst making it easier to recall faulty products and to help fight against counterfeit devices.
In terms of device product types, the approved legislation will seek to:
- strengthen the information and ethical requirements for diagnostic medical devices including those used in pregnancy or DNA testing.
- regulate the raft of products that are currently unregulated, such as contact lenses and liposuction equipment
- increase the scrutiny of high risk devices, such as implants, joint replacements or vascular stents, which will require additional assessments by experts before they can be authorized.
What to expect
Currently, high risk medical devices can be approved if they are able to demonstrate clinical and safety equivalence to an approved product on the market. However, the new regulation sets to make market approval more difficult by requiring additional clinical trials whilst also measuring more relevant outcome data. This in turn, should help ensure a more coherent and robust structure for the governance of high risk devices. The changes include:
- introduction of post-marketing surveillance system
- requirement to have a 'qualified person' responsible for regulatory compliance
- creation of a EU portal where manufactures must report serious incidents and corrective actions taken to reduce the risk of recurrence
- a new medical device coordination group with the power to review and comment on NB assessment of high risk devices
- greater transparency for patients (especially clinical trial participants)
- unique device identification (UDI)
- single registration numbers for all economic operators
- safety and clinical performance summaries for medical devices and IVDs.
Implications for medical device companies
These new changes that govern the medical device sector in the EU represent one of the most disruptive and sweeping changes to impact the whole industry. The EU MDR will lead to very significant changes that will affect all devices currently being marketed in the EU. Manufacturers will need to take a pro-active approach to the new regulation and plan for the transition of existing devices in a timely and meticulous way.
Before implementation in late 2019 or early 2020, there will be a formal procedure whereby the regulatory text will be translated for all EU member languages, followed by formal publication. After publication, expected in late 2016 or early 2017, there will be a three-year transition period.
Manufacturers should therefore start to evaluate the impact and cost implications on their business and plan ahead for these changes.
A step in the right direction
The EU has always been an attractive market for medical devices manufactures due to shorter approval timelines and directives that are less stringent and more innovation friendly compared with the USA. The MDR aims to change none of that but rather bring the much awaited rigor into a business which has been slow in responding to and regulating growing types and complexity of medical devices in last few decades and increasing demand for patient safety.
Regulatory changes have the ability create upheaval regardless of the industry. Companies that stay ahead of the game and act early will be in a position to maintain business as usual while enjoying greater confidence in the safety and quality of their products.
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