1) The new EU medical device regulation MDR (REGULATION EU 2017/745) Enactment: May 2017.
Regulation: the new regulation will replace the original Medical Devices Directive (MDD 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD 90/385/EEC)
2) Mandatory implementation of the MDR regulation: 26th May 2020
Regulation: from the announcement of 26th May 2020 Organizations can not issue CE certificates in accordance with the MDD, the current I * and above risk level product certification bodies are no longer accepted MDD directive certification applications.
3) MDD expiration date: May 27, 2024
Starting from May 27, 2024, all CE certificates of MDD directive held by enterprises will be invalidated.
MDR Certification Essentials: The European Medical Devices Coordination Group (MDCG) has updated a Q&A document on compliance requirements related to notified bodies and joint assessments associated with the upcoming entry into force of the Medical Devices Regulation MDR and the In Vitro Diagnostic Medical Devices Regulation IVDR.
Originally released in early 2019, the Q&A document now covers several new issues that are recommended to be addressed by Notified Bodies when evaluating and certifying medical device and IVD manufacturers under the new regulations:
Supplier and Subcontractor Audits:
For audits of all vendors or subcontractors utilized by a manufacturer, the Notified Body should base its assessment and certification on the MDR Appendix VII in the Recommended Methodology, as well as MDCG's own guidance document, to establish criteria for auditing such entities.MDCG states in the document, "The Notified Body shall establish audit criteria based on the significance of the role it fills."
Re-registration Requirements:
According to the MDCG document, a CE Mark certification is renewed and validity extended under the MDR and IVDR if the Notified Body adopts an appropriate conformity assessment process.
The Notified Body must use the same methodology and process as for the initial certification of the product to determine the recertification of the device. In addition, the Notified Body is responsible for evaluating all MDR or IVDR requirements associated with the audit at least once before the certificate expires.
For ISO 13485 quality system certificates, the Notified Body should evaluate surveillance audits, and include the results of all subcontractor and supplier audits, prior to renewing the certificate.
New Definitions:
The updated Q&A document also provides redefinitions of some relevant terms, such as reappointment.
"Two years of specialized experience" means that a product reviewer within a Notified Body must have two years of specialized experience in the design, manufacture, testing, or use of specific equipment or techniques that have been evaluated for certification. If the professional experience is related to activities performed within a conformity assessment body, such experience must also be at least two years.
The MDCG's clarifications and additions to the Q&A document on Notified Bodies follow the gradual increase in the number of Notified Bodies designated under the new regulation MDR& IVDR.
EU publishes work plan for MDR and IVDR implementation:
The European Commission published on October 9, 2018, a work plan for the implementation of the new EU Medical Devices and In Vitro Diagnostic Devices Regulations (MDR and IVDR).
In this plan, 12 implementing acts/regulations and 12 other initiatives or actions are listed, and the work is described in detail in terms of the legal basis related to the measures, the expected timetable, and the current state of development/next steps. As can be seen from the updated timetable published, only one task has been completed, namely the selection of the size of the organization of the bulletin; all other related work is still in progress or not carried out.