Facilities requesting for remote audits must adhere to requirements such as:
- Communication technologies and tools to be available while adhering to data privacy and security norms
- Required documentation such as audit plans, audit report, Nonconformity Grading and Exchange (NGE) form, etc. to be prepared
- Notified bodies to clearly document that “the audit was performed remotely” and record any aspect of the remote audit that may have not yielded confidence which an on-site audit would have
- The remote surveillance will primarily focus on activities that can be verified remotely, and elements that cannot be verified will be listed in the audit report as deviations to the plan and added to the next on-site audit
Successful remote audits will be issued with validity for 6 months and will be followed by an on-site audit within six months. A successful verification of the recertification process may lead to a certificate with a maximum validity period of 3 years calculated from the expiry date of the prior certificate. In cases where the verification process was unsuccessful, the certification shall be suspended.
The guidance also suggests that notified bodies may consider additional guidance contained in the IAF (International Accreditation Forum) documents while accounting for existing recent audit results with exception of any guidance which contradicts this transmittal.
The guidance ultimately states the notified bodies should consider extraordinary measures on a case-by-case basis to ensure the continual supply of medical devices during the pandemic restrictions.
A co-decision involving the European Parliament and the Council, is required to jointly approve and adopt the legislation that mandates a new implementation date. The EU Parliament along with consultations from the European Economic and Social Committee and the Committee of the Regions will be voting its position in a first reading to be held on the April 16, 2020. Once, the proposal is adopted, it will be implemented into the national laws.
Considering co-decision to be a normal lengthy procedure to reach conciliation, there may be a possibility for EU to indicate enforcement discretion to ensure devices reach patients after May 26, 2020.
Collectively, the notified bodies, manufacturers, and regulatory agencies continue to co-ordinate to maximize efficiency, while implementing the requirements of the MDR amidst the distress as the world navigates through the evolving pandemic.