NEW MEDICAL DEVICES REGULAMENTATION - PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE

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.