Medical device CE marking

Kiwa Cermet Italia S.P.A. 21st NB under the MDR

2021-07

MDR:

On July 15, 2021, the 21st Notified Body under the MDR was designated and included in the NANDO database: Kiwa Cermet Italia S.P.A. (NB #0476) in Italy.

The 20th Notified Body was designated on April 7, 2021: Eurofins Expert Services Oy (NB# 0537) in Finland, the 19th Notified Body was designated on February 16, 2021: Instituto Superiore di Sanita’ (ISS) (NB# 0373) in Italy and the 18th Notified Body on January 9, 2021: SGS FIMKO OY (NB# 0598 / ex-0403), Finland.

Source: NANDO database

IVDR:

The current status of NBs under the IVDR is still 5:

BSI Group The Netherlands B.V. (NB# 2797)
DEKRA Certification B.V. (NB# 0344)
DEKRA Certification GmbH (NB# 0124)
TÜV Rheinland LGA Products GmbH (NB# 0197)
TÜV SÜD Product Service GmbH Zertifizierstellen (NB# 0123)

Source: NANDO database

MDCG 2021-13 Q&A on Actor ID

2021-06

On June 23 the European Commission published MDCG 2021-13: Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR.

The document can be downloaded in our library

Source: European Commission

Update (Rev. 1) on July 12, 2021

MDCG 2021-12 FAQ on EMDN

2021-06

On June 4, the MDCG issued MDCG 2021-12 on FAQ on the European Medical Device Nomenclature (EMDN).

Six questions answered regarding EMDN:
1. What is the European Medical Device Nomenclature (EMDN)?
2. How was the EMDN created?
3. What are the key principles of EMDN?
4. How do I gain access to the EMDN?
5. How is the EMDN structured?
6. Which level of the EMDN should I use to assign a term to my device?

The document can be downloaded in our library

The same document can also be found in our library in a different format / layout, published by the European Commission on June 15, 2021.

Source: European Commission

MDCG published joint implementation plan on IVDR

2021-06

On June 7, the MDCG published  a new joint implementation plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR.

In addition to setting the priorities, the plan will serve as a living document to monitor their implementation. The status and timelines of the items will be updated to reflect the progress of the work.

The document can be downloaded in our library

Source: European Commission

MDCG 2021-10 Status Appendixes E-I IMDRF N48

2021-06

On June 4 the MDCG issued MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices.

For ease of readability, this document intends to provide clarifications as to how certain principles and examples outlined in N48 Appendixes E-I apply under the MDR/IVDR. The examples provided within the Appendixes are for informative purposes and should not be interpreted as the sole manner for complying with UDI obligations. It is recommended that these documents are always read in conjunction with the MDR and the IVDR.

The document can be downloaded in our library

Source: European Commission

Status of the EU-Switzerland Mutual Recognition Agreement (MRA)

2021-05

The European Union and Switzerland have not been able to update the existing MRA to cover the MDR. This means that Switzerland will become a “third country” as regards to medical devices (EU perspective). Devices on the EU market may no longer move freely to the Swiss market. Devices which will be put on the Swiss market have to comply with the Medical Device Ordinance (MedDO).

The European Commission has issued this guidance, it can be downloaded in our library
The Swiss Authorities have published this guidance: Link

Update of the EU-Turkey Customs Union for medical devices

2021-05

The EU-Turkey Customs Union for medical devices, including the signing of an Administrative Arrangement for the transfer of personal data between the European Commission and the Turkish Medicines and Medical Devices Agency, and the Customs Union Joint Committee Statement confirming Turkey’s alignment with the EU Medical Devices Regulation 2017/745 has been concluded.

This confirms the continued integration of Turkey to the EU market on medical devices and the facilitation of trade. As previously mentioned, a similar alignment to enable the continuation of EU-Turkey customs union for in-vitro diagnostic devices will follow.

The document can be downloaded in our library

Source: European Commission

MDCG 2021-08 Clinical investigation application/notification documents

2021-05

On May 21, the MDCG has issued a guidance document, MDCG 2021-08 Clinical investigation application/notification documents, collating a series of clinical investigation application/notification documents to support relevant procedures under the MDR.
These documents include:
– Clinical investigation application/notification form under the MDR (with the same data fields to the Eudamed system in development);
– Addendum to the clinical investigation application/notification form for: additional investigational device(s) (section 3); additional comparator device(s) (section 4); and additional investigation site(s) (section 5);
– Clinical investigation supporting documents ̶ appendix of documents to attach; and
– Checklist of general safety and performance requirements, standards, common specifications and scientific advice.

The document can be downloaded in our library

Source: European Commission