Medical device CE marking

New Manual Borderline and classification (vs. 1.20)

2018-10

The European Commission has updated its manual on borderline and classification.

It includes now:

1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
1.25. Mattress covers against mites
1.22. Lubricants intended for body massages and/or sexual intercourse

8. CLASSIFICATION
8.31. Trial hip prosthesis heads or stems

9. SOFTWARE AND MOBILE APPLICATIONS
9.9. Product intended to facilitate conception based on basal body temperature
9.10. Product intended to facilitate conception and enable contraception based on basal body temperature
9.11. Stand-alone software application for conception and contraception purposes using data entered by the patient

The manual can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

MDCG endorses 5 new documents

2018-10

The European Commission has issued 5 new MDCG endorsed documents:

  • MDCG 2018-3   Guidance on UDI for systems and procedure packs
  • MDCG 2018-4   Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
  • MDCG 2018-5   UDI Assignment to Medical Device Software
  • MDCG 2018-6   Clarifications of UDI related responsibilities in relation to Article 16
  • MDCG 2018-7   Provisional considerations regarding language issues associated with the UDI database

The guidances can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

Guidance for products without an intended medical purpose (MDR, Annex XVI)

2018-10

The MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom) would like to share the following:

By May 2020, some products that do not have an intended medical purpose will be required to comply with the new regulations for medical devices. These groups of products are listed under Annex XVI of the Medical Device Regulations (MDR). Further information about the specific requirements of the MDR on these groups can be found in this leaflet.

The leaflet can be downloaded here: library

Source: https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr

MDCG issues draft guidance on European nomenclature (2018-2)

2018-05

According to Article 26 of the Regulation 745/2017 on medical devices and Article 23 of Regulation 746/2017 on in-vitro diagnostic medical device, the Commission is required to make available a medical device nomenclature to support the functioning of the future EUDAMED.

This document intends to provide a detailed description of requirements and criteria that the future nomenclature is expected to fulfil. This is expected to serve as a reference basis throughout the decision process and will also ensure that all legal and technical issues associated with the future EU medical device nomenclature are properly mapped.

The guidance (2018-2) can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

MDCG issues draft guidance on BASIC UDI-DI (2018-1)

2018-05

The new Medical Device Regulations 745/2017 and 746/2017 introduce a Unique Device Identification (UDI) system for medical devices.

Main provisions related to the establishment of the UDI system are contained in Chapter III and Annex VI of the two medical device Regulations.

The main features of the UDI system and relevant obligations for operators will be provided in a dedicated Q/A paper to be published by the Commission in spring 2018.

This guidance is intended to provide a clarification on the notion of Basic UDI-DI, its use in relevant documentation and the factors triggering UDI-DI changes.

The guidance (2018-1) can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

New Manual Borderline and classification (vs. 1.19)

2018-04

The European Commission has updated its manual on borderline and classification.

It includes now:

1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
1.21. Rugby helmet
1.22. Autopsy saw
1.23. UV flow germicidal lamp
1.24. Water filter

4. BORDERLINE MEDICAL DEVICE – MEDICINAL PRODUCT
4.22. Bone void fillers containing animal growth factors
4.23. Weight management products

8. CLASSIFICATION
8.30. Whole body and partial body cryotherapy chambers

The manual can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

New Manual Borderline and classification (vs. 1.18)

2017-12

The European Commission has updated its manual on borderline and classification.

It includes now:

1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
1.19. Products intended to reduce the effect of alcohol
1.20. Radiation shields

4. BORDERLINE MEDICAL DEVICE – MEDICINAL PRODUCT
4.20. D-mannose for the prevention of urinary tract infections
4.21. Solution of 8-MOP in extracorporeal photochemotherapy

6. BORDERLINE MEDICAL DEVICE –COSMETIC PRODUCTS
6.2. Alum styptic pencils

7. ACCESSORY TO A MEDICAL DEVICE OR AN IN-VITRO DIAGNOSTIC MEDICAL DEVICE
7.5. Microplate washers

8. CLASSIFICATION
8.26. Tissue expanders used in the breast
8.27. Dura guard for use with a craniotome
8.28. Heart bypass cannulae
8.29. Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose

9. SOFTWARE AND MOBILE APPLICATIONS
9.7. Mobile application for managing pictures of moles
9.8. Mobile application for the assessment of moles

The manual can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

Publication of IVDR

2017-05

The European Commission has officially published the in vitro medical device Regulation (IVDR) on the 5th of May, 2017.

The Regulation may be found in our library

IVDR 2017/746/EU:
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Transition:

The official timing for transition start 20 days after the new law is published in the Official Journal. Publication was on May 5th 2017, which means an official transition starting date on May 25th 2017. The Regulation will be fully applicable in five years for in vitro medical devices.

Publication of MDR

2017-05

The European Commission has officially published the medical device Regulation (MDR) on the 5th of May, 2017.

The Regulation may be found in our library

MDR 2017/745/EU:
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Transition:

The official timing for transition start 20 days after the new law is published in the Official Journal. Publication was on May 5th 2017, which means an official transition starting date on May 25th 2017. The Regulation will be fully applicable in three years for medical devices.