12/04/2019 | Press release | Distributed by Public on 12/03/2019 23:52
European MD and IVD Regulations Publications
The EU commission and its working groups are continuing to work on multiple subjects needed to implement the MDR and IVDR, and are regularly publishing new position or guidance documents. Since the last update in March 2019, we take a look at the latest documents that have been published:
MDR and IVDR Corrigendum
MDR and IVDR corrigendum's were adopted on March 13, 2019. These clarify some points of divergent opinion or interpretation that have shown themselves during the designation process for Notified Bodies.
MDR second corrigendum has been released
The Council of European Union has published on November 25, 2019 a second corrigendum to the Medical Devices regulation (EU) 2017//745 known as MDR. This corrigendum is primarily correcting some minor typographic errors but also includes the following in relation to all Class I devices:
You can read the second MDR corrigendum using the following link: Interinstitutional File: 2012/0266 (COD)
Commission implementing decision (EU) 2019/939
Commission implementing decision (EU) 2019/939 of June 6, 2019 was published. This designates issuing entities to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices. This text identifies the following entities:
Commission implementing decision (EU) 2019/1396
Commission implementing decision (EU) 2019/1396 of September 10, 2019, was published. This provides the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council, regarding the designation of expert panels in the field of medical devices.
Manual on borderlines and classification
The manual on borderlines and classification in the community regulatory framework for Medical devices Version 1.22 from May 2019 was published. This defines:
MDCG 2019-10: Application of Transitional Provisions Concerning Validity of Certificates Issued in Accordance to Directives 90/385/EEC and 93/42/EEC was published in October 2019. It explains the need for a new contract between notified bodies and manufacturers to support MDD surveillance activities after May 2020.
MDCG 2019-9: Summary of Safety and Clinical Performance, A guide for Manufacturers and Notified Bodies was published in August 2019. This guidance document details the expected content of SSCP and the review done by NB.
MDCG 2019-5: Registration of Legacy Devices in EUDAMED was published in April 2019. This guidance explains that legacy devices (meaning those covered by a valid directive certificate) that will continue to be placed on the market after the MDR date of application should be registered in EUDAMED without a Basic UDI-DI and UDI-DI.
MDCG 2019-4 Timelines for Registration of Device Data Elements in EUDAMED was published in April 2019. It establishes that the obligation for registration in EUDAMED of device data elements listed in both part A, Section 2, and Part B of Annex VI, shall be applicable as from the timelines indicated in Article 123(3)(e). This means that from 18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of publication of the notice referred to in Article 34(3).
FAQ on UDI System
The FAQ on UDI system was published in August 2019.
The EU Commission has announced that EUDAMED will be launched in May 2022 with a two-year delay compared to initial expectation.
Updates to Standards
A number of standards have been updated, as listed below:
Updates from SGS
Cut-off date for CE certificates
We are implementing a cut-off date at the end of November 2019 to ensure delivery of ongoing CE certificates before May 26, 2020. We will not start any new activities in regard to MDD, meaning that no extension to scopes or recertification or new certification activities will be done after November 30, 2019. As your QMS certificate is still valid for at least two years, we will continue to conduct surveillance activities as the fourth and fifth visits of your cycle, instead of a recertification activity that coordinates with your three-yearly ISO 13485 cycle.
If you want to keep your MDD certificate until the end of validity, we will need to continue MDD surveillance activities, including on-site surveillance audits and sampling of technical documentation.
As an extension to Brexit has been agreed until January 31, 2020, this extends the uncertainty of a Hard Brexit no-deal scenario when, legally, CE certificates issued by UK Notified Bodies will become invalid. We have now made firm commitments to remove uncertainty and offer a single regulatory path for our clients.
For more details please contact your local office.
MDR and IVDR training from SGS
SGS has developed specialized training to accompany your transition to MDR and IVDR, including:
For more information, please contact:
Global Product Manager - Medical Devices Regulation
t: +41 22 739 98 58
Global Product Manager - IVDR
t: +44 (0) 19 345 22 917