New and updated MDCG guidance documents published to support medical device operators

New guidance documents for medical device manufacturers and other operators have been published around the turn of the year to support the application of EU Regulations.

All medical device manufacturers should be familiar with the Regulations concerning their products, that is, the EU Medical Devices Regulation 2017/745 (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).  The requirements of the Regulations are presented at a general level, which is why it is not always possible to unambiguously interpret how the regulation is applied in your case. Expert working groups have prepared MDCG guidance documents to support the interpretation of the Regulations.  Some of the MDCG guidance documents clarify a rather specific topic, such as the content of a periodic safety update report, while others describe the principles of interpreting transitional provisions more broadly.

The European Commission published several new documents around the turn of the year:

• Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2 and Background note on the use of the Manual on borderline and classification for medical devices under the Directives
• MDCG 2022-4 rev.1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD 
• MDCG 2022-17 MDCG Position Paper on "hybrid audits"   
• MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate  
• MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746  
• MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746  
• MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745  
• MDCG 2023-1 Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746  
• MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices  
• All MDCG guidance documents are available on the European Commission’s website.

Unlike the EU Regulations themselves, the MDCG guidance documents are not legally binding. Furthermore, the MDCG guidance documents do not introduce new requirements that do not already exist in the Regulations. MDCG documents support manufacturers, authorities, notified bodies and other operators in the uniform interpretation and application of the requirements of the Regulations. They also seek to provide concrete examples and guidance on the requirements of the Regulations. As the MDCG guidance documents are prepared by MDCG expert working groups and are then approved by the European Commission and the Member States’ joint coordination group (MDCG), they always represent the Member States’ authorities’ common interpretation of the requirements of the Regulations. 

All possible medical devices and situations could not be covered when the MDCG guidance documents were prepared. When reading each guidance document, you should determine what the document is intended for and what it covers. Even in cases where the MDCG guidance document is not entirely suitable for the situation of your device, the guidance document may provide an insight into the principles of interpreting the Regulations. A guidance document may also be deviated from for a well-founded reason. If necessary, you can ask the authorities or your notified body for advice on how to interpret the guidance documents.

Manufacturers should regularly follow the European Commission’s website and new guidance documents: Public Health > Medical Devices - Sector > New Regulations > Guidance Guidance - MDCG endorsed documents and other guidance (europa.eu) 

Fimea also provides Finnish translations for some guidance documents. They are available on our website (in Finnish) by subject.

Read more:

MDCG guidance documents on the European Commission’s website: Guidance - MDCG endorsed documents and other guidance (europa.eu)

MD Regulation: Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

IVD Regulation: Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical device