Key Implementations to compliance with Regulation (EU) 2017/745
As the extended transition deadline 26 May 2021 is approaching, we should be ready for ensuring compliance with EU MDR. We have built a comprehensive plan that outlines the procedures, checklists, specific details and processes that you must follow to better understand and comply with these new EU MDR requirements.
Immense efforts would be required from Manufacturers to meet transition deadline with progress of EU MDR.
- More detailed tracking mechanism i.e., Unique Device Identification (UDI) that allows to trace individual devices throughout the supply chain.
- To obtain an SRN, non-EU manufacturers must submit an Actor Registration Request through EUDAMED as of 1 December 2020. The economic operator will obtain a unique SRN for each actor role.
- As part of post-market surveillance, manufacturers shall be ready to face unannounced audits by Notified Bodies that include product sample checks and product testing; and will also be required to submit annual safety and performance reports where applicable.
- Manufacturers will be expected to consider Common Specifications and put alongside the Harmonized Standards and the State of the Art.
- Update the Technical Documentation to meet higher requirements and expectations of Notified Bodies where involved.
- Clinical Evaluations need to be updated to meet the new regulations and justification may be required for not performing a clinical investigation. Clinical evidence should be sufficient to support clinical claims on performance and safety of medical devices.
Key Points to be understood from the amendment of Regulation (EU) 2017/745:
- Applies to MDR only, no change to IVDR (2017/746)
- The date '26 May 2020' is replaced by '26 May 2021' in this amendment.
- The repeal of the Medical Device Directives (90/385/EEC and 93/42/EEC) is delayed by one year, i.e. repeal by 26 May 2021 (Article 122 Repeal)
- EC shall ensure that EUDAMED is fully functional at a date that allows the Commission to publish the notice by 25 March 2021 (Article 34 Functionality of Eudamed)
- By way of derogation from Article 9(1) and (2) of Directive 90/385/EEC or from Article 11(1) to (6) of Directive 93/42/EEC, any competent authority may authorize, on a duly justified request till 25 May 2021 and may extended using Implementing Acts (Article 59 Derogations from the conformity assessment procedures)
- The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall notify the Commission of those rules and of those measures by 25 February 2021 (Article 113 Penalties)
- There is no extension of MDD Certificates issued in accordance with Directives are valid until 26 May 2024 or end of the period indicated on the certificate, provided that from 26 May 2021. It continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose (Article 120 Transitional provisions)
- Class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 where requires the involvement of a notified body as per the conformity assessment procedure pursuant to this Regulation
- Devices lawfully placed on the market as of May 26, 2021 may continue to be made available until May 26, 2025.
- Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2021.
- Devices manufactured utilizing derivatives of tissues or cells of human origin (Article 1(6) g) have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2021 may continue to be placed on the market and put into service in the Member States concerned.
- Reusable devices shall bear the UDI carrier on the device itself. Implementation dates for Unique Device Identification (UDI) has been updated (Article 123 Entry into force and date of application) as follows:
- implantable devices and class III devices - from 26 May 2023
- class IIA and class IIB devices - from 26 May 2025
- class I devices - from 26 May 2027
The main key point is that there are no amendments taken place in the regulatory requirements of EU MDR regarding Technical, Clinical, PMS, Quality, Labeling and Regulatory aspects. This extended timeline allows the Manufacturers, Notified Bodies, Authorized Representatives and other Economic Operators for more robust planning and implementation to compliance with EU MDR.