On May 26, 2021, the Medical Devices Regulation 2017/745 entered into application. This brought many implications for medical devices manufacturers, regardless of the class. We have previously covered MDR topics, such as how to achieve compliance for Class I medical devices and we will now address the requirements for legacy devices as of the application date.
According to MDR art 120.3, legacy devices are:
- Medical devices that are Upper class or Class I sterile/devices with a measuring function under the Medical Device Directive 93/42/EEC (with a valid CE Certificate under MDD); or
- Class I devices pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to the MDR requires the involvement of a notified body (e.g.: up-classified class I, reusable surgical instrument,…).
Without the legacy concept, all these devices would have required a CE Certificate under MDR on May 26, 2021.
In this sense, due to the difficulties of obtaining such a certificate by the date of application of the Regulation, these devices were granted a grace period. From May 26, 2021, until May 26, 2024, or the date of expiration of their MDD CE Certificates, whatever comes sooner. Provided that they comply with the following requirements: “However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives” (MDR Article 120.3).
Nevertheless, it is important to note that these are not the only MDR requirements to be met for legacy devices. Additionally, as per article 10.9 MDR, it is also necessary to operate a Quality Management System (QMS) in accordance with the Regulation, including a Regulatory Strategy. Most importantly, under the Medical Devices Regulation 2017/745 the Authorised Representative plays a pivotal role in ensuring the devices’ compliance and in serving as the manufacturer’s contact person established in the Union. In this sense, the Authorized Representative is legally liable for defective devices in the event that a non-EU manufacturer has not complied with its general obligations (Article 11(5)). This justifies the EAR assessment of legacy devices to be placed on the market. Furthermore, this interpretation has been confirmed by several Competent Authorities, who have expressed that Articles 10 to 15 of the Medical Devices Regulation are applicable for all classes of devices, including legacy devices.
For this reason, as of May 26, 2021, legacy devices that do not fulfill the above requirements can no longer be placed on the Union market. Moreover, meeting the above requirements is also necessary if you wish to obtain Free Sales Certificates from the Competent Authorities.
Nevertheless, we should mention the most recent MDCG Guidance document emphasizing the application of MDR post-market surveillance, vigilance and registration requirements to legacy devices, while having a PRRC or an implant card for legacy devices is not yet needed in the MDCG’s view.
Do you plan to sell your legacy devices on the EU market? Do you wish to know more about legacy devices and their MDR compliance procedure? Obelis can assist you on your path towards MDR legacy compliance.
Pablo De Mingo Monge
Publications Department
21.10.2021
References:
MDCG. (2021). 2021–25 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC. Retrieved on 21/10/2021 from https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_25_en.pdf
Official Journal of the European Union. (5 April 2017). Regulation (EU) 2017/745 of the European Parliament and of the Council. Retrieved on 21/10/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0745-20200424&from=EN
Vergani, T. (18 May 2021). Class I Medical Devices: Achieve MDR compliance in 9 steps. Retrieved on 21/10/2021 from https://www.obelis.net/news/class-i-medical-devices-achieve-mdr-compliance-in-9-steps/