On August 29, 2017, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published an interactive guide to assist Medical Device and In Vitro Diagnostics (IVD) companies with a comprehensive understanding of the new and different EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) requirements.
The MDR and IVDR entered into European Parliament force on May 25, 2017, which will require EU device manufacturers to be in conformance by the following dates:
- May 26, 2020: MDR/745/2017
- May 26, 2022: IVDR
These regulations will apply with minimal national deviations and define a new European regulatory framework for medical devices and In Vitro Diagnostics products as they emphasize the growing importance of biotechnology and life science sectors.
During the transition period, medical device manufacturers have been given the choice as to which set of requirements they would like to comply with: the current EU Medical Device (MDD) and/or In Vitro Diagnostic Device (IVDR) directives or the new MDR/IVDR regulations. However, a hybrid of both regulations is not allowed.
Following the transition periods for MDR/IVDR regulations, any devices placed on the market in the EU must comply with the new regulations. This includes legacy devices already in commercial distribution and new devices to be placed on the market near or at the application date. An exception of this sunset provision allows certain devices to benefit from the extended Conformité Européene (CE) certificate provisions which allow CE certificates issued within the transition period under the old directives to remain valid for up to four (4) years under the MDR, or two (2) years under the IVDR, from the date of issue.
However, the above extended transition period is subject to specific regulatory requirements. The Notified Body that was responsible for using the directive-based CE certificate must still be in existence and accredited under the new regulations. No significant design changes are possible and stricter post-market surveillance requirements do apply.
NAMSA, upon review of the UK’s interactive guidance document, recommends its use due to the well thought-out, user-friendly structure. Specifically, it summarizes the following aspects of the new EU MDR/IVDR:
- Transition periods for the application of the new regulations;
- New classification categories, including examples of medical devices and IVD devices;
- New category of medical devices previously unregulated “products without an intended medical purpose” (e.g. aesthetic laser equipment, non-corrective contact lenses and brain stimulation equipment), which will be regulated under the MDR;
- Summary of device classes for which a conformity assessment by a Notified Body will be required;
- Overview of the steps that manufacturers must take in order to comply with the MDR/IVDR before placing a device on the market;
- Summary of assigning a unique device identification (UDI-DI) number and entering tracking information in the European EUDAMED database;
- Summary of the new regulatory obligations that apply to different economic operators in the medical device distribution chain (i.e. legal manufacturer, importer, distributor or authorized representative); and
- Overview of the rigorous post-market surveillance (PMS) requirements, including the mandatory requirement to continually collect, analyze and summarize post-market clinical experience data.
The last two aspects above are of critical importance, as they require new collaboration structures. Economic operators must mutually share regulatory compliance data and commonly participate in pro-active and preventative post-market surveillance activities under the new regulations.
- Full MHRA guidance document
- Legislative text of the MDR (2017/745)
- Legislative text of the IVDR (2017/746)
Do you Have an MDR/IVDR Transition Plan in Place?
NAMSA’s global regulatory experts welcome the opportunity to discuss strategic options related to the new EU IVDR/MDR regulations, including the potential business impacts for distributors and importers of medical devices in the EU. Make sure your organization is set up for success!
Contact us at firstname.lastname@example.org, or visit our regulatory consulting webpage here to learn how we can assist your medical device organization with achieving success under the latest regulatory EU landscape.
Stephan Buttron currently serves as NAMSA’s Senior Product Development Strategist. Mr. Buttron has over 20 years’ experience in achieving EU, U.S. FDA and other international regulatory medical device approvals and registrations. He has provided global consulting services on regulatory strategy development to medical device manufacturers regarding least burdensome pathways for 510(k)/PMA and MMD-CE mark applications. He has successfully managed FDA pre-submission meetings for Investigational Device Exemption (IDE) pathways with multiple FDA specialty branches. Stephan is considered a key industry thought leader on risk management, and has provided multiple training sessions to medical device manufacturers on structured risk management process per EN ISO 14971 & EU MDD 93/42 as amended with directive 2007/ 47. Mr. Buttron has also provided countless educational opportunities to international organizations regarding medical device design and development issues related to ISO 13485 & EU MDD 2007/47 compliance.