Slide background
Slide background




General Safety and Performance Requirements (Annex I) MDR

ID 11161 | | Visite: 4026 | Documenti Marcatura CE UEPermalink: https://www.certifico.com/id/11161

General Safety and Performance Requirements  Annex I  MDR

General Safety and Performance Requirements (Annex I) in the New Medical Device Regulation

Comparison with the Essential Requirements of the Medical Device Directive and Active Implantable Device Directive

As compliance with the ‘Essential Requirements (ERs)’ is the keystone for establishing conformity with the Medical Device Directive (MDD, 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD, 90/385/EEC), so too is compliance with the ‘General Safety and Performance Requirements (SPRs)’ in establishing conformity with the recently published Medical Device Regulation – EU Regulation 2017/745 (MDR). The Regulation’s date of publication was 5 May 2017 and date for Entry into Force was 25 May 2017 with a 3-year transition period (postponed 25 May 2021).

The purpose of this white paper is to compare the ERs in the MDD and AIMDD to the SPRs in Annex I of the new MDR. Where there are 13 ERs in the MDD and 16 in the AIMDD, there are 23 SPRs in the new MDR. The overall text and requirements are expanded, but the scope and topics are consistent overall with the previous directives with a few notable exceptions. Some topics such as clinical evaluation and medicinal consultation have moved from the requirements list into the articles, while other topics are new to the requirements list, including devices without a medical purpose and requirements for devices used by lay persons. A number of areas now have increased emphasis and more explicit requirements, which in many cases align with harmonized standards and industry guidances. Importantly, all of these points will now become European law under this Regulation.

The areas in Annex I considered to have highest impact to manufacturers are: 

- medicinal substances (and substances absorbed or locally dispersed); 
- devices incorporating materials of biological origin; 
- substances of concern; 
- labelling requirements; 
- emphasis on cybersecurity.

Other key areas of impact in the MDR outside Annex I include:

- clinical data and evaluation requirements;
- reclassification of some device types;
- post-market requirements.

These topics outside Annex I are beyond the scope of the current white paper, but manufacturers should be aware that these important areas are also changing in comparison to the directives. An updated white paper will follow focusing on the implications of the MDR and MEDDEV 2.7.1 Rev. 4 for clinical data and evaluation.

The paper is organized in order of the new safety and performance requirements by number, with the goal that the readers begin to become familiar with the new numbering and organization. The intent is not to reproduce each requirement, but to highlight areas of particular similarity and difference between the ERs and SPRs.

While many of the SPRs (namely numbers 10-23) have explicit headings or titles, others have been added here in an attempt to highlight the theme of each requirement. Cross-references to ERs and other documents with similar text have been identified for each requirement.

In addition, each SPR has been graded (low, medium or high) relative to the expected impact of the changes to the manufacturer (see Appendix 1 for SPR/ER Cross-reference Mapping Guide). Understanding the SPRs will be an important aspect of manufacturers’ transition plans from the directives to the MDR.

Add more in attachment

Collegati

Descrizione Livello Dimensione Downloads
Allegato riservato General Safety and Performance Requirements (Annex I) MDR.pdf
BSI 2017
228 kB 13

Tags: Marcatura CE Regolamento Dispositivi Medici

Ultimi archiviati Marcatura CE

Ott 29, 2024 112

Decisione (UE) 2024/2779

Decisione (UE) 2024/2779 ID 22821 | 29.10.2024 Decisione (UE) 2024/2779 della Commissione, del 24 ottobre 2024, che istituisce il gruppo di esperti sulla progettazione ecocompatibile dei prodotti sostenibili e sull’etichettatura energetica (forum sulla progettazione ecocompatibile) (GU L 2024/2779… Leggi tutto
Ott 22, 2024 209

Regolamento di esecuzione (UE) 2024/994

Regolamento di esecuzione (UE) 2024/994 / Ecodesign banca dati dei prodotti ID 22773 | 22.10.2024 Regolamento di esecuzione (UE) 2024/994 della Commissione del 2 aprile 2024 recante i dettagli operativi della banca dati dei prodotti istituita a norma del regolamento (UE) 2017/1369 del Parlamento… Leggi tutto
Set 21, 2024 2463

Decreto 17 settembre 2024 n. 133

Decreto 17 settembre 2024 n. 133 ID 22594 | 21.09.2024 Decreto 17 settembre 2024 n. 133 - Regolamento di modifica al decreto 29 luglio 2008, n. 146 concernente il regolamento di attuazione dell'articolo 65 del decreto legislativo 18 luglio 2005, n. 171, recante il codice della nautica da diporto.… Leggi tutto

Più letti Marcatura CE

Nov 08, 2024 117329

Regolamento Prodotti da Costruzione (UE) 305/2011 - CPR

Regolamento CPR (UE) 305/2011 Regolamento (UE) N. 305/2011 del Parlamento Europeo e del Consiglio del 9 marzo 2011 che fissa condizioni armonizzate per la commercializzazione dei prodotti da costruzione e che abroga la direttiva 89/106/CEE del Consiglio (Testo rilevante ai fini del SEE) (GU L 88/10… Leggi tutto