Significant changes

Dear Collegues,

I’m Dr Mattia Nuti and I’m the CEO of an international association of companies called International Checks Group working in the field of Safety and Quality of medical and electromedical devices.

Here i am to introduce you to the new era of MD (Medical Devices), IVD (In Vitro Diagnostic Medical Devices) and AIMD (Active Implantable Medical Devices) and theirs standards latest news.

First of all let me explain the definitions of MD, IVD and AIMD taken from theirs directives:

MD:

“Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap,
  • Investigation, replacement or modification of the anatomy or of a physiological process, or
  • Control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”

IVD:

“Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • concerning a physiological or pathological state, or
  • concerning a congenital abnormality, or
  • to determine the safety and compatibility with potential recipients, or
  • to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.”

AIMD:

“‘Active Medical Device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

“‘Active Implantable Medical Device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.”

Now we can go further about the latest or future changes that will affect the approach on our area of interest:

93/42/EEC:

That’s the primary directive concerning everything about MD and when apply Quality Standards.
We were waiting for the release of the new directive during 2015 but EEC has released only a draft on november 2015 which contains a lot of changes compared to the old one, but i’m not here to discuss about good or bad changes so below there’s the draft of the new directive that probably will be released during 2016:

Directive:
http://data.consilium.europa.eu/doc/document/ST-12040-2015-REV-1/en/pdf

Annex:
http://data.consilium.europa.eu/doc/document/ST-12040-2015-ADD-1/en/pdf

98/79/EEC:

That’s the primary directive concerning everything about IVD and when apply Quality Standards.
Like above here there is the draft of the new directive that probably will be released during 2016:

Directive:
http://data.consilium.europa.eu/doc/document/ST-12042-2015-INIT/en/pdf

Annex:
http://data.consilium.europa.eu/doc/document/ST-12042-2015-ADD-1/en/pdf

ISO 13485:

Represents the requirements for a comprehensive Quality Management System for the design and manufacture of medical devices.
Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971 by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the EC mark and the permission to sell the medical device in the European Union.

Overall, the proposed revisions to the current version of ISO 13485 can be summarized as follows:

• Harmonization of regulatory requirements.

• Inclusion of risk management throughout the QMS.

• Additional clarity with regard to validation, verifi cation, and design activities.

• Strengthening of supplier control processes.

• Increased focus regarding feedback mechanisms.

As the Directives are under revision as well, the harmonization of quality management requirements with product
conformity requirements is essential to creating a complete and consistent approach to global certifi cation.
In all likelihood, some upgrades will be required to your systems.

Here there is the link of BSI White Paper Iso 13485:
http://www.bsigroup.com/en-GB/our-services/medical-device-services/BSI-Medical-Devices-Whitepapers/

ISO 9001:

That is the most widely-adopted quality management systems standard has benefitted millions of organizations globally – with users reporting increased growth and productivity and significantly higher customer satisfaction and retention.

Updated on September 23, every company in 2018 has to be aligned on this update.

Some of the key changes include:

  • Greater emphasis on building a management system suited to each organization’s particular needs
  • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
  • Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
  • Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and what format it should be in
  • Alignment with other key management system standards through the use of a common structure and core text.

New High Level Structure (HLS):

All new standards should respect and share a common consistent core:

  • A common general structure (table of contents): identical chapters, article numbers, and chapter, article or clause titles, etc.
  • Introductory texts for identical articles
  • Identical wording for identical requirements
  • Common terms and core definitions

The characteristics and requirements specific to each standard are inserted into this structure in the appropriate chapters.

Clause 1: Scope
Clause 2: Normative References
Clause 3: Terms and Definitions
Clause 4: Context of the organization

Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operation
Clause 9: Performance evaluation
Clause 10: Improvement

UNANNOUNCED AUDIT:

The recommendation can be considered as one response to the PIP scandal and as the result of the action plan commissioned by the former EU commissioner of health and consumer policy. High profile cases such as the PIP scandal draw more attention to the safety and quality systems in place and triggers the creation of new legislation with stricter requirements on Notified Bodies and manufacturers. As a result, the future possibilities of risks of a similar nature are mitigated and patient safety is improved.
Due to the urgency and importance of this recommendation, its effect will likely be adopted by EU member states with a relatively short transition time.
Manufacturers will be subject to an unannounced audit at least once every three years, and this frequency will need to be increased should the devices bear a high risk.

The Commission Recommendation states that these “unannounced audits” must be unpredictable and without prior notice, so there will be no communication with your company prior to the audit. The Notified Body auditors will present themselves at your premises, and your company must provide immediate and unrestricted access.

Access to your critical sub-contractors and crucial suppliers by the Notified Body may also be required, and will be subject to identical requirements, in situations where this is likely to provide more effective control by the Notified Body. This right of access will need to be covered in your contracts with these suppliers.

Here there is the EEC audit directive, take a look on Annex III for the Unannounced Audit:

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013H0473&from=EN

NOTIFIED BODY:

The new-style joint audit, resulting from a call for stricter EU medtech regulatory controls, seems to be causing a drop in the notified body numbers.
Probably in 2018 the number of notified body from 80 will may reduce to only 8, and of this 8 only 3 will be able to conduct certifications on class III product and IVD.
That will be a real revolution of authority changes and political changes, so every company has to be aligned with new assessment and every company has to choose new consultants and notified body able to attend them to the certifications.

IEC 62353:

Pertains to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or systems, which comply with IEC 60601-1-1988 (second edition) and its amendments and IEC 60601-1- 2005 (third edition) and its amendments, before PUTTING INTO SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof.

There’s no doubt IEC 62353 has made an impact on improving testing standards and raising safety levels. The 2014 edition elevates this to another level, making for a more complete document for manufacturers and medical device end-users. Those who wish to test according to IEC 60601 will appreciate that most of the conventional safety analysers on the market today provide only a small subset of the IEC 60601 requirements and that careful consideration must be given to ensuring that the test setup is correct and that equipment is not damaged during any of the tests done.

The recommendation that IEC 62353 can be used as a standard for end of line testing and testing before going into service is new within the 2014 edition. Uniformity in test procedures, time (and cost) savings and a simplified means of analysing test data are among other significant benefits v for those who have made the transition to testing in accordance with IEC 62353.

I think that this article could help you in your business finding new strategy for the changes above.
I will be pleased to answer to your question about Safety and Quality of Medical devices, In Vitro Diagnostic and Active Implantable Medical Devices.

Here there are our contact, keep free to contact us:

www.internationalchecksgroup.com

https://www.linkedin.com/in/mattia-nuti-032511109

www.avconsultingitalia.com

https://www.linkedin.com/in/avconsulting/it

Slán libh!

Updated: 29 novembre 2015 — 14:54

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