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:
- Authorizing all Class I devices including Class I reusable devices that are covered by a declaration of conformity to MDD 93/42/EEC signed before May 26, 2020 to be placed on the market or put into service until May 26, 2024. This will give a potential additional four (4) year period of time to all Class I manufacturers to comply with MDR requirements and get a Notified Body involved in the conformity assessment of their class I reusable devices
- Delaying requirements associated to EUDAMED to 18 months after the date EUDAMED will become functional what is now planned in May 2022
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:
- GS1 AISBL
- Health Industry Business Communications Council (HIBCC)
- Informationsstelle für Arzneispezialitäten — IFA GmbH
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:
- Lubricants intended for alleviation of vaginal dryness are class IIa MD
- Automated external defibrillator storage unit is a class I MD if intended to maintain the specified environmental conditions required for an AED to perform as intended. It is not considered as an MD if it is not supporting this specific function
- Medication decision support software is qualified as an MD
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:
- ISO 10993-1: 2018 – Biological Evaluation of Medical Devices – Part 1: evaluation and testing within a risk management process – Updated and published by ISO, but not yet harmonized by the EU
- ISO 20916: 2019 – In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
- ISO/IEC GUIDE 63:2019 – guide to the development and inclusion of aspects of safety in international standards for medical devices
- ISO 19223:2019 – Lung ventilators and related equipment — Vocabulary and semantics
- ISO 16054:2019 – Implants for surgery — Minimum data sets for surgical implants
- ISO/TS 11633-1:2019 – Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis
- ISO 20069:2019 – Guidance for assessment and evaluation of changes to drug delivery systems
- ISO 8600-3:2019 Endoscopes — Medical endoscopes and endotherapy devices — Part 3: Determination of field of view and direction of view of endoscopes with optics
- New Third Edition of standard expected for publication in 2019 - ISO 14155: Role of Risk Management in Clinical Investigations. Expected to align more closely with ISO 14971 requirements. In addition, ISO14971 (2019) harmonized with MDR is expected soon.
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.
- We remain committed to migrate all Medical Device clients from SGS UK (NB0120) to SGS Belgium NV (NB1639), and the mass migration will happen on November 30, 2019
- MDR will be completed as urgently as possible under NB1639 (SGS Belgium NV)
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:
- eLearning modules for a quick overview on MDR and IVDR
- MDR Training - two-day course (face-to-face) In addition, a new IVDR Training course on IVDR Technical Documentation requirements will be released
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