On 1 December 2017 a new Regulation on the Registration, Conformity Assessment, Distribution, Operation and Technical Supervision of Medical Devices (“Latvian MDR”) entered into force.
The new Latvian MDR is intended as an interim measure until two new EU Regulations ‒ 2017/745 on medical devices (“EU MDR”) and 2017/746 on in vitro diagnostic medical devices (“EU IVDMDR”) ‒ become applicable (26 May 2020 and 26 May 2022 respectively).
The Latvian MDR implements several new principles compared to the previous regulatory framework. Most of these stem from EU directives effective until the EU MDR and EU IVDMDR apply:
Sole representative of a non-EU manufacturer
The Latvian MDR requires a manufacturer placing a medical device (“MD”) on the market under its own name and without a registered place of business in any Member State to designate a sole authorised representative in the EU: more than one representative is prohibited. The representative must have a registered place of business in an EU Member State. The Latvian MDR also lists the documents to be presented by a representative with a registered place of business in Latvia.
Adjusted traceability, vigilance and liability system
The Latvian State Medicines Agency (“Agency”) will not register a MD manufactured in Latvia by examining the MD documentation, but will only collect information on MD manufacturers registered in Latvia. Additionally the Agency will obtain information on Class II a, II b and III MD, in vitro diagnostic MD within the notification procedure.
In addition to the EUDAMED database, traceability in Latvia is ensured by the national LATMED database maintained by the Agency. Although a proposal to avoid double notification in EU and Latvian databases was rejected, the rules on notification have eased.
Under previous regulations, LATMED included information on all MD authorized in Latvia, as well as on EU in vitro diagnostic MD ‒ and other MD ‒ notified for introduction to the Latvian market. Under the new Latvian MDR, the following data related to MD will be included in the national database: (i) notified Class II a, II b and III MD, in vitro diagnostic A list, B list and self-test MD, as well as active implantable MD; (ii) manufacturers of Class I MD, in vitro diagnostic MD, custom-made MD, and persons assembling MD whose place of business is in Latvia (particular MD will no longer be registered in the database); (iii) authorized representatives of manufacturers with no place of business in any EEA Member State.
Distributors of Class II a, II b and III MD plus implantable and active implantable MD must maintain ‒ and on request present to the Agency ‒ data on when and to whom a MD was supplied over the previous ten years.
The Latvian MDR requires health care institutions to notify the Agency, the manufacturer (or its authorized representative or distributor) of any incidents involving a MD. In turn, the manufacturer or its authorized representative or distributor must notify the Agency, the Latvian Health Inspectorate as well as any health care institutions involved of any medical or technical reasons related to the characteristics or operation of a MD due to which the manufacturer regularly exempts MD of the same model from the market.
The law sets further detailed obligations for persons concerned after incidents involving MD.
In general, the manufacturer bears liability for the safety of a MD (including vigilance procedures). The manufacturer is wholly liable for investigating an incident.
In turn, the head of a health care institution is liable for observing the laws governing MD within their institution, as well as compliance with the system for operating a MD set up and implemented within that institution. However, this does not release the manufacturer from general liability for the safety of MD.
Additionally, liability for MD introduced to Latvia via the notification procedure lies on the applicant (e.g. distributor) who launches the product on the market. Under the Latvian MDR, the holder or possessor of a MD (additionally to the manufacturer) is liable for proper use of Class II a, II b and III MD, as well as any implantable or invasive MD, regardless of whether or not they are used in a health care institution or used on the basis of medical indications. In any case the Latvian Health Inspectorate can require corrective measures from the holder or possessor in the case of violations of laws governing MD.
The law does not set sanctions specific to vigilance notification. Sanctions are foreseen only for failing to present information requested by an authority, or for violating rules governing sales or rendering services (including MD-related), or for sale or offering for sale goods of improper quality (e.g. unsafe MD) as such.
In any case, if an incident occurs the Agency can impose temporary restrictions (restricting or forbidding use of MD) or require recall of a product from the market.
Personal use of MD by patients themselves
Under the new Latvian MDR, the manufacturer of a MD must consider (i) measures to decrease the risk of a user’s mistake; and (ii) the knowledge, experience, education and training of intended users, and, if applicable, the medical and physical condition of a person (professional or non-professional user, disabled person and other users).
As a result, the liability of users (patients) is minimized.
Mutual recognition in EU countries
The Latvian MDR establishes free sale certificates. The Agency may issue a certificate to a manufacturer with a place of business in Latvia for CE marked MD manufactured in Latvia and which can be introduced to the market under Latvian law.
In Latvia all information must be given in Latvian. Certain information must be provided additionally in English (the name of a MD or modifications to certain MD manufactured in Latvia). The Latvian MDR foresees that some technical documentation might be in a foreign language, in which case the manufacturer must provide a Latvian translation within 30 days from a request by the Latvian Health Inspectorate unless the Inspectorate sets a shorter term due to significant and immediate risks.
Free sale certificates are to be issued in Latvian and English.
Rules on advertising
Unlike in the case of pharmaceuticals, Latvian law still does not restrict advertising of MD. Only a couple of general restrictions affect Health Care Professionals in accepting benefits related to supply of MD.
Discussions are ongoing as to whether disclosure rules similar to those governing promotion of pharmaceuticals must also be adopted in relation to promoting MD. Specific measures will be elaborated later, coincidentally with the drafting of further amendments to the Latvian MDR required for implementing certain provisions of the EU MDR and EU IVDMDR.
Source: Ministru kabineta 2017.gada 28.novembra noteikumi Nr.689 “Medicīnisko ierīču reģistrācijas, atbilstības novērtēšanas, izplatīšanas, ekspluatācijas un tehniskās uzraudzības kārtība”, likumi.lv/ta/id/295401