The European Medical Device Regulation (EU MDR) is actually a set of regulations that governs the manufacturing and distribution of medical devices in Europe. Compliance with the EU MDR is mandatory for any medical device manufacturer that wants to sell their products on the European marketplace. The officially termed Regulation (EU) 2017/745 on Medical Devices became applicable in the European Union on May 26, 2021 when it replaced the Medical Devices Directive also known as MDD (93/42/EEC) and the Active Implantable Medical Devices Directive also known as AIMD (90/385/EEC). The Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) previously came into effect in May 2017 to replace the Active Implantable Medical Devices Directive also known as IVDD (98/79/EC).
If you plan to enter the UK market (no longer part of the EU), your products need to have a UK Conformity Assessed (UKCA) mark, which was passed as a law by the UK government on January 1, 2021. The UKCA transition period is currently set for 30 June 2023 and the certification should be conducted by notified bodies to have the UKCA marking on your device.
Overall, MDR and IVDR introduce significant changes to the medical device industry. These are major changes that affect your compliance process, quality management system, and technical documentation, depending on the device type as well as your role as a manufacturer, importer, or authorized representative.
Any existing MDD certificates will remain valid until the expiry date or until May 26, 2024 – whichever comes first. A Notified Body performs surveillance activities until the MDD certificate expires.
Medical device manufacturers should be aware that MDD-certified devices cannot undergo significant changes after May 26, 2020, or the certificate must be migrated to EU MDR.
Class I medical devices can be self-certified, and any manufacturer can prepare the required technical documentation without being audited. If the classification of the medical device is higher than Class I, such as Class Is/Im/Ir, IIa, IIb, or III, every manufacturer needs a Notified Body to get certified.
Notified Bodies must first meet the expectations of the EU Commission in order to become accredited. These entities have a vital function in supporting medical device manufacturers to produce EU MDR-compliant medical devices for the EU market by issuing a conformity certificate upon completion of the assessment (i.e., if a medical device conforms to EU MDR requirements).
Additionally, Notified Bodies play a new role to implement the regulation through follow-up surveillance audits (including unannounced audits) of manufacturing processes and quality management systems. The EU MDR imposed stricter requirements on Notified Bodies as well.
The EU Commission also made significantly more rigid changes to assess Notified Bodies under the EU MDR. As a consequence, there are fewer Notified Bodies. Currently, 50 entities present under the MDD, but only 28 are listed under MDR on the NANDO MDR database. However, this number is increasing slowly. Nevertheless, an increase in medical devices are expected to require Notified Body conformity assessments as new medium-risk Class I devices.
Any legal manufacturer should apply for EU MDR certifications (if applicable), which will initiate a new certification cycle, valid for up to five years. Prior to certification being granted, the legal manufacturer should complete the Notified Body’s review of technical files and initial on-site audit activity to verify implementation. Typically, this review is based on sampling, but Class IIb and Class III medical devices are not permitted for sampling.
If you have already been certified by MDD in the past, you know what it involves and how to comply with. And the MDR may seem like just a revision of MDD and you may assume you can comply with it easily. However, MDR is almost three times more detailed than MDD. That’s exactly why we recommend to treat this as a new regulation. Overall, the MDD concepts and the requirements remain part of the new legislation; however, notable additional requirements have been added and significant changes made.
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