Luca Martinelli
Publication 25th November 2016
1.FOREWORD
It’s appropriate to underline that
as of today (25.11.2016) the Official Journal has not published yet the new
regulation. This fact doesn’t prevent to make some considerations about some
new features in the final draft.
The new Regulation of the European
Parliament of the Council on medical devices, amending Directive 2001/83/CE, Regulation
(CE) nr. 178/2002 and Regulation (CE) nr. 1223/2009 will replace Directives 90/385/CEE
“on the approximation of the States member relating the active implantable
medical devices” and 93/42/CEE “on medical devices”, establishes the figure of
the “person responsible for regulatory compliance”.
2.PERSON RESPONSIBLE FOR REGULATORY
COMPLIANCE
2.1 Who is him?
The new Regulation requires that the
manufacturer must ensure that the supervision and control of medical devices
manufacturing, as well as the supervisory and post-market surveillance
activities related to them, are carried out within the organization of the
manufacturer by a person responsible for regulatory compliance in
fulfillment of minimum qualification requirements.
2.2 What should he do?
The person responsible for regulatory
compliance has got the task of ensuring that at least:
1-
The compliance of the devices is adequately controlled
in accordance with the quality management system according to which the devices
are manufactured, before a product (medical device) is relased
2-
The technical documentation and declaration of
conformity are established and updated
3-
Met the post-market surveillance obligations according
to the reference articles
4-
Accident reporting obligations would be satisfied
5-
In case of under investigation devices, would be
issued the declaration foreseen
2.3 What qualification should have
he?
The person responsible for regulatory
compliance must have a deep knowledge in the field of medical devices.
These knowledge can be demonstrated woth a certificate from one of the
following qualifications:
1-
diploma, certificate or other evidence of obtained
university studies or a recognized course as equivalent by the member state
concerned in medicine, pharmacy, engineering or other rilevant fields and at
least two years of professional experience in the field of regulation or
quality management systems related to devices.
Alternatively:
2- five years of professional
experience in the field of regulation connected to the devices, including
experience in quality management systems.
3.WHO IS OBLIGED TO HAVE THIS
PROFESSIONAL?
3.1 The manufacturer
The manufacturer based in the EU
must ensure that the supervision and control of the production of medical
devices, as well as the supervisory activities and post-marketing surveillance,
are carried out within its organization by a person responsible for regulatory
compliance have the minimum qualification requirements.
3.2 The agent
Similarly the appointed
representative in the European Union, that is, the one who plays the role of
the manufacturer’s representative who is based outside the European Union, ha
salso the obligation to have a person responsible for regulatory compliance.
It must have permanently and
continuously. The person in charge must possess specialized knowledge in the
field of regulations applicable to medical devices in the European Union.
Specialized knowledge shall be proved by one of the following qualifications:
1- diploma, certificate or other
evidence of obtained university studies or a recognized course as equivalent by
the member state concerned in medicine, pharmacy, engineering or other rilevant
fields and at least two years of professional experience in the field of
regulation or quality management systems related to devices.
Alternatively:
2- five years of professional
experience in the field of regulation connected to the devices, including
experience in quality management systems.
In this case the qualification
requirements of the person responsible for regulatory compliance are
different only in part b).
It’s not requested experience
related to the field of regulation with more experience in quality system
management but experience related to the field of regulation or, alternatively,
experience in quality system management related to medical devices.
4. REGISTRATION IN EUROPEAN DATABASE
On registration of devices in the
European database (UDI), the manufaturers, agents and importers where
applicable will also indicate the name, address, and contact details of the person
responsible for the regulatory compliance.
5.DEROGATION AND AXCEPTIONS
5.1 Custom medical devices
manufacturer
The Custom medical devices
manufacturer is a particular figure, which doesn’t meet the manufacturer’s
standards of in series manufactured devices (eg. the dental technician).
To these the possession of
specialized knowledge is demonstrated by at least two years of professional
experience in the manufacture of devices.
This rule may vary depending on the
provisions relating professional qualifications in force in the European Union
member countries.
5.2 Micro and small enterprises
manufacturer
Micro and small enterprises within
the meaning of Recommendation 2003/361/CE are not required to have a person
responsible for regulatory compliance within their organization but are
required to have it available in a permanent and continuous basis.
Staff headcount and thresholds in
the Commission Recommendation, which define the categories of companies:
1- The category of micro, small and medium-sized
enterprises which employ fewer than 250 persons and which have an annual
turnover not exceeding EUR 50 million or whose annual balance sheet total not
exceeding 43 million Euro;
2- Within the SME category, a small
enterprise is defined as an enterprise employing less thank 50 persons and
whose annual turnover or annual balance sheet total not exceeding 10 million
Euro;
3- In the SME category, a
microenterprise is defined as an enterprise employing less than 10 persons and
whose annual turnover or annual balance sheet total not exceeding EUR 2 million.
6. EXTENSIONS OF THE MANUFACTURER’S
OBLIGATIONS
Depending on the activity,
importers, distributors or other natural or legal persons assume the same
obligations of the manufacturers in the event that:
1- put a device available on the
market under its own name, its trade name or registered trade mark, except in
cases where a distributor or importer make an agreement with a manufacturer by
means of which the manufacturer is identified as such on the label and it is
responsible for meeting the obligations incumbent on manufacturers;
2- from changing the destination of
a device already placed on the market or put into service;
3- modify a device already placed on
the market or put into service so that its compliance with applicable
requirements may be affected.
The first subparagraph shall not
apply to persons who, although not considered a manufacturer as defined in the
Regulation, mountain or adapt to its destination for a specific patient an existing
device on the market.
7. CONTRACTUAL RELATIONSHIP
The regulation does not indicate the
type of contractual relationship between the manufacturer and the person
responsible for regulatory compliance because it is not necessary that a
company may have a person with the necessary qualifications.
Hence, the role can also be covered
by:
1- An external consultant with which
the manufacturer gives the task of periodic, continuous, permanent and
systematic presence;
2- A consultant with whom the manufacturer,
in the case of micro or small enterprise, make a contract where the consultanti
s available permanently and continuously.
About this
matter we recollect that on the role of Head of the Prevention and Protection
Service in response to a ruling (response of 04/11/2014 Prot.
37/0018423/MA007.A001 ruling 24/2014) the Ministry of work clarified that:
Omissis
“La modifica
introdotta dal Decreto Legge n. 69/2013, convertito in Legge n. 98/2013, pone
in capo al datore di lavoro l’obbligo di organizzare il SPP (Servizio di
Prevenzione e Protezione) prioritariamente all’interno.
Appare
evidente che il legislatore abbia voluto sottrarre la scelta al datore di
lavoro la facoltà di optare liberamente fra servizi esterni ed interni
favorendo la scelta di quest’ultimo. A norma poi del comma 4 del suddetto
articolo il ricorso a persone o servizi esterni è obbligatorio in assenza di
dipendenti che, all’interno dell’azienda ovvero dell’unità produttiva, siano in
possesso dei requisiti di cui all’articolo 32."
Omissis
“Tale
previsione è ovviamente motivata dalla necessità di assicurare una presenza
costante e continuativa del servizio prevenzione all’interno dell’azienda”
Omissis
“In tale
quadro, dunque, il termine interno non può intendersi
equivalente alla definizione di dipendente, ma deve essere
sostanzialmente riferito ad un lavoratore che assicuri una presenza adeguata
per lo svolgimento della propria attività.”
7.CONCLUSIONS
- The new regulation of medical devices introduces the
figure of person responsible for regulatory compliance - PRRC.
- The person responsible for regulatory compliance has got a high degree
of specialization. He has experience training and working specific and cross in
technical, regulatory and operational.
- The person responsible for regulatory compliance can be a consultant or
an employee.
