MEDICAL DEVICES

MEDICAL DEVICES. REGULATORY FRAMEWORK

https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en

The new Regulations on medical devices

On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives.

•Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 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

https://eur-lex.europa.eu/legal-content/ES/TXT/PDF/?uri=CELEX:32017R0745&from=EN

•Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

https://eur-lex.europa.eu/legal-content/ES/TXT/PDF/?uri=CELEX:32017R0746&from=EN

The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746:

https://eur-lex.europa.eu/legal-content/ES/TXT/PDF/?uri=CELEX:32017R2185&from=EN

As of 26 November 2017, conformity assessment bodies may apply for designation as notified bodies under Regulations (EU) 2017/745 and 2017/746. Guidance documents and forms are available in MDCG documents. This explanatory note provides answers to the most frequent questions asked about the designation process, and in particular the scheduling of joint assessments:

MDCG DOCUMENTS:

MDCG endorsed documents

MDCG 2018-1 Draft guidance on basic UDI-DI and changes to UDI-DI March 2018

MDCG 2018-2 Future EU medical device nomenclature – Description of requirements March 2018

Designation of notified bodies under the new Regulations on medical devices

Notified BODIES

Designation of notified bodies under the new Regulations on medical devices

1. Best practice guidance on designation and notification of conformity assessment bodies (NBOG BPG 2017-1)

2. Best practice guidance on the information required for conformity assessment bodies' personnel involved in conformity assessment activities (NBOG BPG 2017-2)

3. Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices Regulation (MDR) (NBOG F 2017-1)

4. Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices Regulation (IVDR) (NBOG F 2017-2)

5. Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) (NBOG F 2017-3)

6. Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) (NBOG F 2017-4)

7. Preliminary assessment review template (MDR) (NBOG F 2017-5)

8. Preliminary assessment review template (IVDR) (NBOG F 2017-6)

9. Review of qualification for the authorisation of personnel (MDR) (NBOG F 2017-7)

10. Review of qualification for the authorisation of personnel (IVDR) (NBOG F 2017-8)

Other documents

UDIWG 2018-1 UDI database. Definitions, descriptions and formats of the UDI core elements March 2018

UDIWG 2018-2 The architecture of the UDI database - Basic UDI-DI and UDI-DI attributes for medical devices and in-vitro diagnostic medical devices

INFORMATION NOTE ON JOINT ASSESSMENTS UNDER THE NEW REGULATION ON MEDICAL DEVICES:

Information note on joint assessments under the new regulations on Medical Devices (113 KB)

List of Guidance MEDDEVs

See below a complete list of all Guidance Meddevs, including links to further information:

2.1 Scope, field of application, definition

MEDDEV 2.1/1 (18 kB) Definitions of “medical devices”, “accessory” and “manufacturer” April 1994

MEDDEV 2.1/2 rev.2 (14 kB) Field of application of directive “active implantable medical devices” April 1994

MEDDEV 2.1/2.1 (12 kB) Treatment of Computers Used to Program Implantable Pulse Generators February 1998

MEDDEV 2.1/3 rev.3 (183 kB) Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative December 2009

MEDDEV 2.1/4 (21 kB) Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment March 1994

For the relation between the MDD and directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009 (28 kB)

MEDDEV 2.1/5 (10 kB) Medical devices with a measuring function June 1998

MEDDEV 2.1/6 (514 kB) Qualification and Classification of stand alone software July 2016

2.2 Essential requirements

MEDDEV 2.2/1 rev.1 (16 kB) EMC requirements February 1998

MEDDEV 2.2/3 rev.3 (17 kB) “Use by”-date June 1998

MEDDEV 2.2/4 (38 kB) Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products January 2012

2.4 Classification of MD

MEDDEV 2.4/1 rev.9 (759 kB) Classification of medical devices June 2010

2.5 Conformity assessment procedure

General rules

Quality assurance.

Regulatory auditing of quality systems of medical device manufacturers (See document in the GHTF-Global Harmonization Task Force)

MEDDEV 2.5/3 rev.2 (8 kB) Subcontracting quality systems related June 1998

MEDDEV 2.5/5 rev.3 (7 kB) Translation procedure February 1998

MEDDEV 2.5/6 rev.1 (9 kB) Homogenous batches (verification of manufacturers' products) February 1998

Conformity assessment for particular groups of products

MEDDEV 2.5/7 rev.1 (92 kB) Conformity assessment of breast implants July 1998

MEDDEV 2.5/9 rev.1 (96 kB) Evaluation of medical devices incorporating products containing natural rubber latex February 2004

MEDDEV 2.5/10 (80 kB) Guideline for Authorised Representatives January 2012

2.7

Clinical investigation, clinical evaluation

MEDDEV 2.7/1 rev.4 (631 kB) Clinical evaluation: Guide for manufacturers and notified bodies June 2016

Appendix 1: Clinical evaluation on coronary stents (100 kB) December 2008

MEDDEV 2.7/2 rev. 2 (412 kB) Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC September 2015

MEDDEV 2.7/3 rev. 3 (383 kB) Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC - SAE reporting form (27 kB)

May 2015

The new SAE reporting form will be taken in use 1 September 2016 at the latest.

MEDDEV 2.7/4 (183 kB) Guidelines on Clinical investigations: a guide for manufacturers and notified bodies December 2010

2.10 Notified bodies

The documents on designation of notified bodies under the new Regulations are in the section above (MDCG documents)

MEDDEV 2.10/2 rev.1 (105 kB) Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices

Annex 1 (119 kB), Annex 2 (14 kB), Annex 3 (16 kB), Annex 4 (26 kB) April 2001

2.12

Market surveillance

MEDDEV 2.12/1 rev.8 (763 kB) Guidelines on a Medical Devices Vigilance System January 2013

Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms

MEDDEV 2.12/1 rev. 7 MIR and FSCA are still valid

Active PDF forms

How to use FSCA and MIR forms (12 kB)

Manufacturer Incident Report - MIR (971 kB)

Field Safety Corrective Action - FSCA (1 MB)

MIR and FSCA xml files

Please note: Some browser plugins are not compatible with PDF forms. If you have problems opening these forms, please save them to your computer and open them from there.

Other forms and templates

Field Safety Notice Template (27 kB)

Trend Report (151 kB)

Periodic Summary Report (192 kB)

Ⅱ. Device Specific Vigilance Guidance

DSVG Template (22 kB)

DSVG 00 (20 kB) Introduction to Device Specific Vigilance Guidance

DSVG 01 (24 kB) Cardiac Ablation Vigilance Reporting Guidance

DSVG 02 (26 kB) Coronary Stents Vigilance Reporting Guidance

MEDDEV 2.12/2 rev.2 (228 kB) Post Market Clinical Follow-up studies January 2012

2.13 Transitional period

MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) August 1998

As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009 (35 kB)

2.14 IVD

MEDDEV 2.14/1 rev.2 (76 kB) Borderline and Classification issues. A guide for manufacturers and notified bodies January 2012

MEDDEV 2.14/2 rev.1 (64 kB) Research Use Only products February 2004

MEDDEV 2.14/3 rev.1 (80 kB) Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices January 2007

Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device

Directive, Article 10 (213 kB) January 2007

MEDDEV 2.14/4 (114 kB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP January 2012

2.15

Other guidances

MEDDEV 2.15 rev.3 (32 kB) Committees/Working Groups contributing to the implementation of the Medical Device Directives December 2008

CONSENSUS STATEMENTS

· Guidance Notes for Manufacturers of Class Ⅰ Medical Devices (52 kB) endorsed by the MDEG on December 2009

· Guidance Notes for Manufacturers of Custom-Made Medical Devices (51 kB) endorsed by the MDEG on June 2010

· Guidance document on Dir. 2005/50/EC (32 kB) endorsed by the MDEG on December 2006

· IVD Trisomy 21 (13 kB) endorsed by the MDEG on December 2006

· IVD Rare Blood Groups (20 kB) endorsed by the MDEG on December 2003

INFORMATIVE DOCUMENTS

· Informative document of the Commission’s services on placing on the market of medical devices (16 November 2010, 30 kB)

· Information on the Customs Union Agreement with Turkey in the field of medical devices (11 February 2010, 32 kB)

o Decision No 1/2006 of the EC-Turkey Association Council of 15 May 2006 on the implementation of Article 9 of Decision No 1/95 of the EC-Turkey Association Council on implementing the final phase of the Customs Union

o Statement of Turkey – EC Customs Union Joint Committee on the implementation of Article 1 of Decision 1/2006 (88 kB)

· Information on the relation between the revised Directives 90/385/EEC and 93/42/EEC concerning (active implantable) medical devices and Directive 2006/42/EC on machinery (21 August 2009, 21 kB)

· Information on the relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment (21 August 2009, 28 kB)

· Informative document of the Commission’s services on implementation of directive 2007/47/EC amending directives 90/385/EEC, 9342/EEC and 98/8/EC (5 June 2009, 35 kB)

· Information on the Medical Devices Directives in relation to medical device own brand labellers (4 February 2008, 17 kB)

Current medical devices Directives

Ranging from simple sticking plasters and contact lenses to sophisticated pacemakers and hip replacements, medical devices and in vitro diagnostic medical devices are important to our health and quality of life. People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation.

Medical devices within the EU are currently regulated by the following 3 directives:

· Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)

· Council Directive 93/42/EEC on Medical Devices (MDD) (1993)

· Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998)

Implementing measures for Directives

The Commission has adopted several implementing measures based on the Medical Devices Directives. These measures concern, among others, medical devices manufactured using tissues of animal origin, the classification of certain medical devices and Common Technical Specifications for In vitro diagnostics (IVDs)s, listed in Annex Ⅱof the IVD Directive.

See key documents on recommendations, classification and other amending and implementing legislation below:

RECOMMENDATIONS

· Commission Recommendation 2013/172/EU of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union

· Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices

CLASSIFICATION

· Commission Recommendation of 24 September 2013 - OJ L 253/27 of 25 September 2013

· Reclassification of hip, knee and shoulder joint replacements:

o Directive 2005/50/EC - OJ L 210/41 of 12 August 2005

· Reclassification of breast implants:

o Directive 2003/12/EC - OJ L 28/43 of 04 February 2003

OTHER AMENDING AND IMPLEMENTION LEGISLATION

· Cranberries

o Commission Implementing Decision (EU) 2017/1445 – OJ L 207 8 August 2017

· Notified Bodies

o Commission Implementing Regulation (EU) No 920/2013 - OJ L 523 of 25 September2013

· Electronic instructions for use of medical devices