It is less than one year until the end of the European Medical Device Regulation’s (EU MDR) transition period – May 26, 2020 – and Class I manufacturers cannot afford to fall behind on compliance. Now is the time to act and comply with the new regulation to ensure proper certifications are issued to continue to sell products in the EU market.
Lack of urgency in complying with the new regulation may be due to manufacturers’ misperceptions, such as the assumption that only industry competitors manufacturing high-risk devices are required to conform with the EU MDR. Dispelling this myth could not be more crucial.
The new EU MDR brings significant changes to the medical device industry, with new classification rules being one of the most important. For Class I manufacturers to face the impending challenges, the following points help provide a clear pathway to compliance.
1.Take a close look
Publication of the MDR in 2017 opened a new chapter for manufacturers trading in the EU market. The MDR establishes that within the three-year transition period, all manufacturers will have to fall under one of three obligations to continue trading products in the EU. Manufacturers can re-certify under the Medical Devices Directive (MDD) or self-certify under the new requirements of the MDR, while manufacturers producing up-classified devices will need notified body review before the deadline. The first obligation states that if a product is recertified under the MDD (before May 25, 2020) manufacturers can take advantage of an extended transition period until May 2024. However, Class I devices have no EU certificate so there is no extended transition period and all new MDR requirements apply immediately on May 26, 2020.
Another change that Class I manufacturers need to consider is that regulations previously didn’t require a formal Quality Management System (QMS) under MDD, but starting on May 26, 2020, all manufacturers will require a formal QMS as per MDR Article 10, paragraph 9, best served by implementing EN ISO 13485:2016.
2. Self-certification: MDD vs MDR
MDD and the MDR present significant differences that Class I manufacturers should not overlook. Under the MDD, non-sterile Class I products without a measuring function can obtain CE-marking through self-certification in accordance with Annex VII.
Although Class I manufacturers can certify conformity of their own products through the EU declaration of conformity (MDR Article 19), they will still need to provide a comprehensive and detailed technical file. Self-certification conditions within the MDR are well defined; if the device doesn’t require a classification change and stays a Class I product, manufacturers can then continue to self-certify as long as they fulfill MDR requirements. The accuracy of their technical documentation must meet these requirements in time for the deadline, as well as self-declare the conformity of the devices with the requirements and register those details on the EUDAMED database.
3. New classifications, rules
The MDR increases classifications from 18 to 22 – new regulations establish new classifications – and includes important changes to current rules. Reusable surgical instruments are a prime example. Although they are already Class I and don’t require notified body review, they will fall under a new classification of Class I devices – Class Ir (reusable surgical instruments) – and this classification requires a notified body to look at cleaning, repackaging, and reprocessing elements.
To have a clear idea of where new classifications apply and how new conformity assessment routes are changing, manufacturers need to fully understand MDR Annex VIII. Devices that have been up classified to Class IIa or IIb, Class III, or any subsection of Class I, will have to seek notified body review for certification. It’s fundamental that Class I manufacturers don’t underestimate the required additional input, time, preparation, and resources required to demonstrate total EU MDR compliance.
4. Early notified body engagement
Be aware of the significant deficiency of notified bodies across Europe, causing a shortage of regulatory expertise. Manufacturers failing to act now risk not knowing if their device has been up classified, subsequently risking their notified body already operating at full capacity and unable to review their technical documentation in time for the deadline.
5. Clinical evidence
The EU MDR does not allow for grandfathering products. Even if a device has been on the market for two decades it requires a new CE mark to comply with the MDR. While manufacturers wait for notified bodies to be designated under the MDR, they should be working on sourcing the appropriate clinical evidence for their devices to be CE marked. If devices do not meet compliance standards by May 25, 2020, they will be removed from the market and manufacturers won’t be able to gather the appropriate clinical evidence the MDR requires.
Additionally, Class I manufacturers will need to draw up a formal Post Market Surveillance (PMS) report and include it in their QMS. Once the PMS has been put together it’s the manufacturer’s responsibility to keep it up to date with the latest clinical evidence. Acting now means that already available post-market clinical data can be used; moreover, a post-market study can be performed and submitted as clinical evidence within the technical documentation.
MDR compliance needs to be at the top of manufacturers’ priorities, otherwise they face being locked out of the EU market, risking cash-flow repercussions and business reputations. The clock is ticking and the advantages of early compliance to the EU MDR should not be underestimated by Class I manufacturers.